The Effect of Partner-Assisted Rebozo Application in the Intrapartum Period on Birth Fear, Pain and Satisfaction

NCT06887608 | Enrolling By Invitation

• 1 other identifier: 27.01.2025-1187899
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The World Health Organization (WHO) recommends the use of non-pharmacological methods for the relief of labor pain. The use of non-pharmacological methods in pain management helps women see their labor as a natural event and contributes to the reduction of cesarean section rates by increasing satisfaction with normal birth . The rebozo technique, a traditional method, originates from Latin America and is a non-invasive, non-drug practical application. The rebozo technique reduces or eliminates pain by creating rhythmic movements in the pelvic area. No study has been found evaluating the results of partner-assisted rebozo application in the intrapartum period. For this reason, it is important to conduct evidence-based studies examining the effects of the use of rebozo technique in labor. This randomized controlled study will contribute to the literature. For this purpose, this study was planned to examine the effects of partner-assisted rebozo application in the intrapartum period on fear of labor, pain, and labor satisfaction.

Conditions

Rebozo at Birth

Keywords

birth, rebozo, fear of birth, birth pain, satisfaction

Outcome Measures

Primary Outcomes (3)

• Visual analog scale (VAS)

  Visual analog scale (VAS): The pain levels of the participants will be evaluated with the Visual analog scale (VAS). It was developed by Bond and Pilowski in 1966 in order to describe the severity of pain in individuals numerically. This measurement tool is a 10 cm long ruler. While the expression "no pain" is written on the left end, the expression "unbearable pain" is written on the right end. Since it has linear properties, the difference between each increase is equal. It is the most commonly used single-dimensional scale type because it does not guide individuals with numbers due to its usage feature, the evaluation is easy and fast, and it gives results in a short time. A VAS value approaching 10 indicates that the pain is very severe, while a value approaching 0 is evaluated as the pain has decreased.

  8 hours

• Birth Satisfaction Scale:

  Birth Satisfaction Scale: Participants' satisfaction levels will be assessed with the Birth Satisfaction Scale. The scale, which was developed to assess women's perceptions of birth, was developed by Martin and Fleming in 2009. Its Turkish validity and reliability were made by Çoşar Çetin and colleagues in 2015. The scale is Likert-type and is scored from 5 (Strongly agree) to 1 (Strongly disagree). Items 4, 8, 12, 15, 16, 17, 19, 20, 21, 23, 25, and 29 are scored reversely. The scale has 30 items and the possible score varies between 30-150. There is no cut-off point for the scale. As the score increases, satisfaction with birth increases. The scale has 3 sub-dimensions: Quality of care (home assessment, birth environment, adequate support and communication with healthcare personnel), personal characteristics of women (ability to cope with birth, sense of control, preparation for birth, communication with the baby), and stress experienced during the birth process (experiencing distre

  8 hours

• Fear of Childbirth Scale:

  Fear of Childbirth Scale: Participants' fear levels will be assessed with the Fear of Childbirth Scale. The scale measures fear during childbirth. The scale, developed by Wijma et al. (2002), was validated in Turkish by Serçekuş et al. in 2017 for validity and reliability. The scale measuring fear during childbirth consists of 10 items. The scale takes 30-90 seconds to administer. Each item in the scale is asked to be scored from 1 (completely disagree) to 10 (completely agree). The possible scores from the scale are between 10-100. A high score indicates high fear. It is an extremely practical scale in terms of application. 5 items (1,3,5,7,10) in the scale are positive and 5 items (2,4,6,8,9) are negative. The 5 items with positive meanings on the scale are reverse scored. The scale can be applied to all multiparous and primiparous women who are admitted to the delivery room and have cervical dilatation of 3 cm or more. The Cronbach alpha reliability coefficient of the scale is 0.88

  8 hours

Study Arms (3)

husband supported rebozo group

EXPERIMENTAL

In the partner-assisted rebozo group, information will be provided to the partner and the pregnant woman with the education booklet created during the latent phase and training will be provided. When the pregnant woman reaches 4-5 cm, 6-7 cm and 8-9 cm vaginal dilation, the data collection forms and scale forms determined for the pregnant woman in the partner-assisted rebozo group will be filled in before the rebozo application. Rebozo application will be applied to the pregnant woman for three contractions. A re-evaluation will be made after the rebozo application. The determined scales will be applied at the 4th hour in the postpartum period.

Other: Husband assisted rebozo application

midwife assisted rebozo group

EXPERIMENTAL

In the midwife-assisted rebozo group, information will be provided to the pregnant woman with the education booklet created during the latent phase and training will be provided. When the pregnant woman reaches 4-5 cm, 6-7 cm and 8-9 cm vaginal dilation, the data collection forms and scale forms determined for the pregnant woman in the midwife-assisted rebozo group will be filled in before the rebozo application. Rebozo application will be applied to the pregnant woman for three contractions. A re-evaluation will be made after the rebozo application. The determined scales will be applied at the 4th hour in the postpartum period.

Other: Midwife assisted rebozo application

control group

NO INTERVENTION

In the control group, when the pregnant woman reaches 4-5 cm, 6-7 cm and 8-9 cm vaginal opening, the same measurements will be made and the woman will continue to receive routine care, and then the measurements will be repeated. In the 4th hour after birth, the determined scales will be applied.

Interventions

Husband assisted rebozo application OTHER

At 4-5 cm, 6-7 cm and 8-9 cm, the pregnant woman will be given a rebozo by her husband.

husband supported rebozo group

Midwife assisted rebozo application OTHER

The midwife will apply rebozo to the pregnant woman at 4-5 cm, 6-7 cm and 8-9 cm.

midwife assisted rebozo group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women who are coming to birth and are 4-5 cm dilated in their first pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being literate,
• Knowing Turkish,
• Being over 18 years of age,
• Being primiparous,
• Having a single fetus and cephalic presentation,
• Being at term (37-42 weeks),
• Not having risk factors during pregnancy (Preeclampsia, premature rupture of membranes, oligohydramnios and polyhydramnios, gestational diabetes, placental anomalies, intrauterine growth retardation, intrauterine dead fetus, fetal distress, macrosomic babies, etc.),
• Being in the active phase of the first stage of labor,
• Those who agree to participate in the research,
• The spouse also agrees to participate in the research.

You may not qualify if:

• Being multiparous,
• Having multiple pregnancies,
• Women with any chronic disease,
• Women with a diagnosed psychiatric disease,
• Pregnant women with spine and bone structure problems.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul Training and Research Hospital

Zeytinburnu, Istanbul, 34020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• DİLAN C Phd Candidate

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: In order to increase the reliability of the research and to distribute the groups homogeneously, groups will be assigned from the website www.randomizer.org. Pregnant women belonging to all three groups will be assigned to the groups through this website.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Phd Candidate

Model Details: It was designed as a randomized controlled experimental study.

Study Record Dates

• First Submitted: March 16, 2025
• First Posted: March 20, 2025
• Study Start: July 22, 2025
• Primary Completion: May 20, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)