Labor Pain, Satisfaction Trial in Balikesir (Foccusing on Maryam's Flower) | Clincosm (2022)

Sponsor

Balikesir University (Other)

Overall Status

Completed

CT.gov ID

NCT04393870

Collaborator

(none)

124

Enrollment

1

Location

2

Arms

9

Actual Duration (Months)

13.7

Patients Per Site Per Month

Objective: To determine the effect that focusing attention on the plant, Maryam's Flower, hason pregnant women's perception of pain, level of comfort and labor satisfaction during thefirst phase of labor.

Method: This randomized controlled experimental study was conducted with an interventiongroup (n=61) and control group (n=63) involving primipara pregnant women who were at 1 cmcervical dilatation. The pregnant women in the intervention group were asked to focus theirattention on Maryam's flower opening its leaf buds and imagine the labor's progress duringthe course of their labor. The control group only received standard midwifery care. Eachgroup was administered the VAS at specific times (at 4-5 cm, 6-7 cm, and 8-9 cm cervicaldilatation) to determine their level of labor pain. The Childbirth Comfort Questionnaire(CCQ) was also administered when the women were at 4-5 cm and 8-9 cm cervical dilatation todetermine their level of birth comfort. The duration of labor was monitored using apartograph form. Finally, the Birth Satisfaction Scale was applied to determine the women'ssatisfaction with the labor in the 2nd hour of the postpartum period.

  • Labor Pain
  • Satisfaction
  • Other: Foccusing on Maryam's Flower
N/A

Design and Settings This randomized controlled experimental study was conducted in thedelivery room of the Atatürk City Hospital in Balıkesir, Turkey between the dates of May 2019and January 2020.

Participants The sample size was determined using G * Power 3 power calculations, taking intoconsideration previous studies on the effect of positive mental imagination during labor.Impact predictions were obtained from the findings derived from Yavari et al., whichspecified the pain intensity during 6-7 cm cervical dilatation to be 6.73 ± 1.34 in thepositive mental imagination group, and 7.63 ± 1.64 in the control group (18). This studyexpected to detect differences similar to those reported by Yavari et al. The sample size wasdetermined to be 61 for each group. Maryam's flower group included 61 pregnant women, whilethe control group included 63 pregnant women. In the Maryam's flower group, 6 pregnant womenand in the control group, 2 pregnant women underwent cesarean sections, therefore, the studywas completed with 55 pregnant women from the Maryam's flower group and 61 pregnant womenfrom the control group (The pregnant women underwent cesarean sections after 6-7 cm cervicaldilatation). The power analysis indicated that the sample size of the study had a power of94% with α = 0.05. The decrease observed in labor pain for the Maryam's flower group at 6-7cm cervical dilatation had an effect size of 0.59 when compared to the control group.

Study inclusion criteria included pregnant women who expected vaginal delivery and a singlehealthy fetus, who were primipara and in the first phase of the labor, and who were at 1 cmcervical dilatation. Pregnant women who were multipara, had a risky pregnancy, a child withcomplications, multiple pregnancies, or a premature delivery and those who delivered after 1cm cervical dilatation were excluded from the study.

Single-blind block randomization was performed with closed opaque envelopes, where 61 of the124 envelopes include pieces of paper on which were written "intervention" and 63 on whichwere written "control". The randomization sequence was determined by a statistician through acomputerized research randomizer. The intervention group focused on Maryam's flowerthroughout the delivery, while the control group was provided standard midwifery care.

Data Collection The participating pregnant women who were in the first phase of labor and at1 cm cervical dilatation were administered an introductory information form. In theintervention group, Maryam's flower was placed in a bowl of water once the women were at 1 cmcervical dilatation, and the pregnant women were asked to focus on the plant. Each group,that is, the intervention group and the control group, were administered the Visual AnalogScale (VAS-1) when they were at 4-5 cm cervical dilatation and the Childbirth ComfortQuestionnaire, to detect their levels of birth comfort, and the VAS-2 when they were at 6-7cm cervical dilatation. Once the women reached 8-10 cm cervical dilation, they were asked torespond to the VAS-3 and Childbirth Comfort Questionnaire. The Birth Satisfaction Scale wasused to determine the level of postnatal satisfaction.

Measures The study data were collected through the Pregnant Information Form, the VAS, thePartograph form, the Childbirth Comfort Questionnaire, and the Birth Satisfaction Scale.

The Pregnant Information Form (PIF): This form included questions on the sociodemographic,gynecological, and obstetric characteristics of the pregnant women.

Visual Analog Scale (VAS): This scale was used to determine the level of labor pain. Thescale features a 10-cm long vertical line, with 0 at the bottom end and 10 at the top end.The VAS was administered when the women were at 4-5 cm, 6-7 cm, and 8-10 cm cervicaldilatation, and the women completed the scale themselves Partograph Form: This form was usedto determine the duration of the first phase of the labor process (active phase andtransition phase).

Childbirth Comfort Questionnaire (CCQ): This questionnaire was developed by Kerri DurnellSchuling and Carolyn Sampselle in 2003 (7). The Turkish reliability and validity study of thequestionnaire was conducted by Potur et al. (2015) (11), who reported that the CCQ includedphysical, environmental, and psychospiritual subscales and relief and transcendence levels.The questionnaire features 9 items, each of which are evaluated based on a 5-pointLikert-type scale, where 1 represented strongly disagree and 5 represented strongly agree.The minimum and maximum scores possible on the scale are 9 and 45, respectively, with higherscores representing higher levels of comfort and lower scores representing lower levels.Potur et al. found Cronbach's alpha reliability coefficient to be 0.75. The CCQ wasadministered twice in this study, once at 4-5 cm cervical dilatation and once at 8-9 cmcervical dilatation.

The Birth Satisfaction Scale (BSS): The Turkish reliability and validity study of this scaledeveloped by Hollins Martin and Fleming was conducted by Çoşar et al. (2015). The scale is aLikert-type scale comprised of 30 questions. The minimum and maximum scores possible on thescale are 30 and 150, respectively. Higher scores indicate higher birth satisfaction. Ananalysis conducted to determine the internal consistency of the BSS found the Cronbach'salpha value to be 0.62. The BSS was administered at the 2nd hour of the postnatal period.

Intervention Maryam's flower was placed in a bowl of water and left in the room of thepregnant women who were at 1 cm cervical dilatation and in the first phase of the labor. Itwas explained to the pregnant women that the leaves of the plant would open up in the water,and they were asked to imagine that the birth canal would simultaneously open up. In effect,they were told to focus on the opening of these leaves during the course of the labor(Pictures 1 and 2). All the pregnant women, those in the control group and in interventiongroup, were provided with standard midwifery care. As part of the standard midwifery caregiven to the pregnant women, follow-up of cervical dilatation and effacement, contraction,fetal heart rate, and vital signs were monitored. The pregnant women were given informationon breathing and pushing techniques. Moreover, induction was performed on all the pregnantwomen. in labor.

Study Type:

Interventional

Actual Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

Effect of Focusing on Maryam's Flower During the First Phase of the Labor

Actual Study Start Date :

May 1, 2019

Actual Primary Completion Date :

Jan 31, 2020

Actual Study Completion Date :

Jan 31, 2020

ArmIntervention/Treatment
Experimental: Maryam's Flower Group

Maryam's flower was placed in a bowl of water and left in the room of the pregnant women who were at 1 cm cervical dilatation and in the first phase of the labor. It was explained to the pregnant women that the leaves of the plant would open up in the water, and they were asked to imagine that the birth canal would simultaneously open up. In effect, they were told to focus on the opening of these leaves during the course of the labor

Other: Foccusing on Maryam's Flower

Effect of Focusing on Maryam's Flower During the First Phase of the labor

No Intervention: Control Group

All the pregnant women, those in the control group, were provided with standard midwifery care.

  1. severity of labor pain by VAS [immediately after the intervention]

    Visual Analog Scale The scale features a 10-cm long vertical line, with 0 at the bottom end and 10 at the top end

  2. duration of active phase and transition phase of labor (4-10cm cervical dilatation) [during the procedure]

    duration of active phase and transition phase of labor (4-10cm cervical dilatation)

  3. comfort level at labor [immediately after the intervention]

    Childbirth Comfort Questionnaire (CCQ) 5-point Likert-type- minimum 9 and maximum 45 points are obtained from the scale. higher scores mean a better comfort

  1. birth satisfaction level. [2nd hour of the postnatal period.]

    The Birth Satisfaction Scale, Likert-type scale- minimum 30 and maximum 150 points are obtained from the scale. higher scores mean a better birth satisfaction

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

  • multipara

  • risky pregnancy

  • child with complications

  • multiple pregnancies

  • premature delivery

  • after 1 cm cervical dilatation

SiteCityStateCountryPostal Code
1Hülya TÜRKMENBalikesirTurkey10100
  • Balikesir University
None specified.None provided.
None provided.

Responsible Party:

Hülya TÜRKMEN, Lecturer (PhD), Balikesir University

ClinicalTrials.gov Identifier:

NCT04393870

Other Study ID Numbers:

  • BalıkesirH

First Posted:

May 19, 2020

Last Update Posted:

May 19, 2020

Last Verified:

May 1, 2020

Individual Participant Data (IPD) Sharing Statement:

No

Plan to Share IPD:

No

Studies a U.S. FDA-regulated Drug Product:

No

Studies a U.S. FDA-regulated Device Product:

No

Keywords provided by Hülya TÜRKMEN, Lecturer (PhD), Balikesir University

comfort at labor

labor pain

Maryam's flower

focused attention

birth satisfaction

Additional relevant MeSH terms:

No Results Posted as of May 19, 2020

Here are the non-pharmacologic techniques in pain management during labour.. Regardless of technique, the goal is to find a breathing pattern that has a calming and relaxing effect.. In the first stage of labour, these breathing techniques can promote physical relaxation by reducing muscle tension.. Warm and cold therapies are basic measures for pain management.. According to a study, warm compresses help the muscles relax thereby decreasing or eliminating the pain.. One study finds that as the mother relaxes through this method it helps reduce the duration of labour and decreases the need for epidural analgesia.. Mental imagery is also a powerful tool in managing labour pain.. Anaesthetics relieve the pain by blocking all sensation of it.. Furthermore, the pain relief provided by these medications can either be systemic , regional , or local .. Some patients have a drop in blood pressure or develop shivering or fever while on the epidural.. Very rarely do patients get a headache or suffer nerve injury (less than 0.1%).. It will take 10-20 minutes before you can feel any effect.

The investigator examined each sample vaginally to determine her cervical dilatation and assessed her level of comfort by using maternal comfort assessment tool the women in upright position group had significantly shorter phase of maximum slope of in labour and facilitating uterine contractions & increasing comfort to the mother.. Miquelutti et al(2007) conducted a explanatory study to assess the effectiveness of upright position during first stage of labour during first stage of labour to improve obstetrical and perinatal outcome.. Lawrence et al (2009) conducted a randomized clinical trial to evaluate maternal comfort & decrease length of labour by providing walking and upright positions at Townsville hospital Queensland Australia with the sample of 3706 pregnant primigravida mothers they were using random and quasi random sampling for comfort and experimental group in experimental group who are different upright position and walking the investigator concluded that the first stage of labour approximately one hour shorter than in a recumbent positions and other outcomes labour it will increase well being of mothers & foetus. Souja et al (2006) in an article a study to evaluate to reduce the length of the first stage of labour by providing ambulation and upright positions at Brazil the investigator used Randomised control trials carried to assess the effect of ambulation the investigator found that the ambulation in the first stage of labour will improve maternal comfort & reduce the length of labour.. The investigator selected 275 labour women are randomly assigned as control group and experimental group, control group were not given any specific position and experimental group were given ambulation.. The investigator selected 48 parturient mothers as experimental group they were given ambulation and another 55mothers are control group they were not given any ambulation.. The investigator concluded that the ambulation in first stage of labour will improve maternal and foetal out come.. Ambulation for experimental group epidural anaesthesia for control group the investigator found that there is difference in experimental group than control group ambulation will improve maternal comfort& Reduce length of labour.. While the teens group (P= 0.01 and P= .003) similar results were observed for intensity P= .01 and unpleasantness P=.03 pain assessed just before delivery .The investigator found that there is no significant difference between all 3 group but first group has received back pain during labour.. Lee & chang hang (2000) conducted a quantitative study to assess the effectiveness sp6 acupressure on labour pain and delivery time in labour the investigator selected randomised clinical trial at university attached hospital with the sample size of 75 labour women randomly assigned n=36 were experimental group n=39 were control group according to parity ,cervical dilatation ,rupture of membranes and labour stage .. The investigation found that all methods are effective to reduce labour pain .Increase, maternal comfort and out come of labour.

Duration (Months). Patients Per Site Per Month. Randomization will be stratified for 1previous chemotherapy for metastatic disease. (yes/no) and 2disease status (Stage IVB primary versus recurrent disease).. Subjects without evidence of disease progression after completion or discontinuation of the. study treatment will be followed until radiographic disease progression, withdrawal of. consent or death.. Study Start Date. :. Progression free survival [1.5 years after LPI] Primary objective:. The purpose of this trial is to determine if chemotherapy (carboplatin/paclitaxel) plus Nintedanib (BIBF 1120) can improve progression free survival compared to chemotherapy (carboplatin/paclitaxel) plus placebo in patients with advanced or recurrent cervical cancer.. Overall survival [5 years after LPI] To evaluate the response rate according to RECIST 1.1. Patient health status [5 years after LPI] To explore the effect of Nintedanib on patient reported health status as measured by EORTC-QOL-Cx 24 and EORTCQLQ-C30 questionnaires. Female subjects more than 18 years of age. Centrally located tumors with radiographic evidence (CT or MRI) of local invasion of. major blood vessels.. Treatment with other investigational drugs or treatment in another clinical trial. within the past 4 weeks before start of therapy or concomitantly with the trial.. Significant cardiovascular diseases ( i.e. uncontrolled hypertension, unstable angina. within the past 6 months, history of infarction within the past 12 months prior to. start of study treatment, congestive heart failure > NYHA II, serious cardiac. arrhythmia, pericardial effusion).. For Pts with liver metastases: total bilirubin. outside of normal limits, ALT or AST > 2.5 ULN. Serious illness or concomitant non-oncological disease such as neurologic,. psychiatric, infectious disease or active ulcers (gastro-intestinal tract, skin) or. laboratory abnormality that may increase the risk associated with study participation. or study drug administration and in the judgment of the investigator would make the. patient inappropriate for entry into the study.

И наша встреча сейчас посвящена только одному – я прошу придерживаться этой канвы, – это не просто вопросы и ответы, хотя, если я смогу, я с удовольствием отвечу на те вопросы, которые у вас есть, но мне бы, честно говоря, хотелось поговорить с вами как с представителями научного образовательного сообщества, с тем чтобы учесть это в подготовке тех документов, которые будут подготовлены в результате проведения мероприятия, о котором я сказал, – Госсовет и Совет по науке при Президенте.. И если бы мы сегодня смогли в рамках Международного года [языков коренных народов] или – мы приветствуем – Десятилетия [Международное десятилетие языков коренных народов, объявленное ООН с 2022 по 2032 год] такие события восстановить, потому что там 200 мест и всегда четыре языковые группы: финно-угорские, самодийские, палеоазиатские и тюркские языки коренных малочисленных народов всего Севера, Сибири и Дальнего Востока, это для нас было бы по–настоящему стартом и сигналом даже в субъектах вернуть когда–то ликвидированные и сокращающиеся языковые кафедры на местах в региональных университетах.. И если не будет его национализации — не в том плане, как сейчас происходит, что когда-нибудь, в неведомо каком поколении этот правящий слой национализируется, и то не понятно, в какую сторону национализируется, а в плане реальной чистки авгиевых конюшен, — ничего хорошего у нас не будет.. При том, например, что в преддверии президентских выборов в России (на которых, как и предполагалось, с убедительным результатом свыше 76% победил действующий глава государства Владимир Путин) лидеры Германии, Великобритании, Франции и США уже выступили единым фронтом, признав в совместном заявлении, что "разумного альтернативного объяснения", кроме предоставленной британской стороной информации "о чрезвычайно вероятной причастности России" к отравлению экс-полковника ГРУ Сергею Скрипаля и его дочери Юлии в Лондоне нервно-паралитическим веществом, не существует.. Потому что фильм, просмотренный на маленьком экранчике компьютера, или фильм на телевидении, нашпигованный рекламой так, что не понять, то ли ты кино смотришь с рекламными вставками, то ли рекламу с обрывками фильма, — это совсем не то, что фильм, на который приходишь с семьёй в кинотеатр, а вокруг море людей, и уже через десять-пятнадцать минут после того, как в переполненном зале гаснет свет, вы начинаете дышать в унисон, реагировать в унисон, и от образов на белой простыне экрана рождается стократно усиленная эмоция.. В одном и том же ряду русскогово­рящих евреев, покинувших Советский Союз в конце 1970-х (так называемая третья волна) и в конце 1980-х (четвертая волна, которая принесла многих этнических русских вместе с русскоговорящими евреями), есть две катего­рии: те, кто влился в религиозное государство (Израиль), основывают свое политическое поведение на светских ценностях, тогда как те, кто влился в го­сударство, не придерживающееся какой-то одной религии как государствен­ной (Соединенные Штаты), основывают свое поведение на религиозной идентичности.

The amount of pain felt during labor and delivery is different for every woman.. There are two general ways to relieve pain during labor and delivery: using medications and using "natural" methods (no medications).. A woman should discuss the many aspects of labor with her health care provider well before labor begins to ensure that she understands all of the options, risks, and benefits of pain relief during labor and delivery before making a decision.. It is important for women to discuss medications with their health care provider before going into labor to ensure that they are making informed decisions about pain relief.. 3 Several types of regional analgesia can be given during labor: Epidural analgesia, also called an epidural block or an epidural, causes loss of feeling in the lower body while the patient stays awake.. Usually, a spinal block is given only once during labor, to help with pain during delivery.. The company of others who offer reassurance, advice, or other help throughout labor, also known as continuous labor support 7 , 8 Relaxation techniques, such as deep breathing, music therapy, or biofeedback A soothing atmosphere Moving and changing positions frequently Using a birthing ball Massage Yoga Taking a bath or shower Hypnosis Using soothing scents (aromatherapy) Acupuncture or acupressure Applying small doses of electrical stimulation to nerve fibers to activate the body's own pain-relieving substances (called transcutaneous electrical nerve stimulation, or TENS) Injecting sterile water into the lower back, which can relieve the intense discomfort and pain in the lower back known as back labor. FAQ: Medications for pain relief during labor and delivery.. The nature and management of labor pain: Part I. Nonpharmacologic pain relief.

This is a randomized, double-blind,. placebo-controlled study of single and multiple dosing, with multiple dosing once daily for 5. days.. A total of 7. coronaviruses have been found, in which HCoV-229E, HCoV-OC43, HCoV-NL63 and HCoV-HKU1 mainly. lead to mild and self-limiting upper respiratory tract infections in infected humans, such as. common cold; two new types of β-coronaviruses have emerged in the past 12 years, namely. severe acute respiratory syndrome (SARS-CoV) and Middle East respiratory syndrome (MERS-CoV),. and these two viruses can cause severe human diseases.. This is a randomized, double-blind,. placebo-controlled study of single and multiple dosing, with multiple dosing once daily for 5. days.. A Randomized, Double-Blind, Placebo-Controlled, Bridging Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of FB2001 in Healthy Subjects. Subjects will be administered with FB2001 by intravenous (IV) infusion. The subject has severe cardiovascular disease, neurological disease, hematological. disease, infectious disease, mental disorder, liver disease, gastrointestinal disease,. lung disease, endocrine disease, immune disease or kidney disease, or has a history of. the above diseases, or other symptoms known to interfere with the absorption,. distribution, metabolism, or excretion of the medicine, or other conditions that the. investigator believes will increase the risk of the subject and might interfere with. the study conduct and results interpretation;. Female subjects who are pregnant, lactating or have pregnancy plans in the 3 months. after their study completion;. Subjects who participated in any other clinical study within 3 months prior to. screening;. Blood donation or blood loss ≥400mL within 3 months prior to drug administration, or. blood transfusion; Blood donation (including component blood donation) or blood loss. ≥200mL within 1 month before drug administration;

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