- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03648099
Effect of Labor Dance and Music on Labor Pain and Fear of Childbirth
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study was designed as a single-blind randomized controlled trial with one control and two intervention groups. The aim of the study was to investigate the effect of labor dance and music used in the active phase of labor on perceived labor pain and fear of childbirth.
The hypotheses of our study are as follows:
H1: The labor dance used in the active phase of labor has an effect on reducing the perceived labor pain.
H2: The music used in the active phase of labor has an effect on reducing the perceived labor pain.
H3: The labor dance used in the active phase of labor has an effect on reducing the fear of childbirth.
H4: The music used in the active phase of labor has an effect on reducing the fear of childbirth.
H5: The labor dance is a more effective method in reducing the labor pain perceived in the active phase of labor compared to music.
H6: The labor dance is a more effective method in reducing the fear of childbirth in the active phase of labor compared to music.
There were three groups in the study: the dance group (D) which involved pregnant women who performed the labor dance; the music group (M) involving pregnant women who were exposed to music; the control group (C) which included pregnant women who were administered routine hospital practices. The sampling included pregnant women who met the inclusion criteria and agreed to participate in the study. D; The pregnant women performed labor dance when the cervical dilatation reached 4-5 cm. The dance was performed in the company of music played through headphones. The labor dance lasted 30 minutes. M; The pregnant women listened to music for 30 minutes when the cervical dilatation reached 4-5 cm. They took any position they wanted while listening to music. C; No intervention was made to relieve the labor pain and reduce the fear of childbirth in the control group of the study. They were administered routine hospital applications.The study data were collected using a Personal Information Form, the Labor Monitoring Form, the Visual Analogue Scale (VAS), and version A of the Wijma Delivery Expectancy Questionnaire (W-DEQA). After the pregnant women were randomly assigned to groups, the personal information form was filled in. The perceived pain and fear of the pregnant women in group D and group M were measured and recorded prior to the intervention (when cervical dilatation reached 4-5 cm). A 30-minute long intervention was administered in groups D and M. The pain and fear measurements were repeated soon after the intervention, 30 minutes and 60 minutes after the intervention. On the other hand, the pain and fear assessments in the control group were made when the cervical dilatation reached 4-5 cm. The assessment of the perceived pain and fear in controls who were administered routine hospital practices were repeated 30 minutes after the first measurement, after 60 minutes, and after 90 minutes .
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ankara
-
Altındağ, Ankara, Turkey, 06340
- Ankara University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- An indication for vaginal delivery
- Primipara
- Cervical dilatation of 3 cm or over
- Full-term pregnancy (38-42 gestational weeks)
- Single healthy fetus in vertex position
- No complication that can cause dystocia in labor (such as contraction anomalies, birth object, birth canal associated dystocia, maternal psychology associated dystocia)
- Not using analgesia and anesthesia during the first phase of the labor
- Having no physical disability to dance
- Having no difficulty to take upright position and move
- Having no communication problem.
Exclusion Criteria:
- Giving up participating in the study
- Abnormal changes in fetal heartbeat
- Emergence of an unexpected complication in the pregnant woman or the fetus 4) Taking analgesics and anesthesia
5) Incomplete intervention and follow-up due to rapid labor 6) Being taken to C/S before the completion of the intervention and follow-up.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Labor Dance and music groups
|
The dance group which involved pregnant women who performed the labor dance
The music group involving pregnant women who were exposed to music.
|
No Intervention: Control group
The control group: No intervention was made to relieve the labor pain and reduce the fear of childbirth in the control group of the study.
They were administered routine hospital applications.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogue Scale Score,
Time Frame: Baseline
|
The perceived pain pregnant women in groups were measured and recorded prior to the intervention (when cervical dilatation reached 4-5 cm). Assessed the labor pain level with Visual Analogue Scale score. This is a 10 cm scale which is labeled "no pain" at one end and "severe pain" at the other end. (0=no pain; 10= pain as bad as can be). Increasing scores indicate women's labor pain. |
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Version A of the Wijma Delivery Expectancy Questionnaire Score
Time Frame: Baseline
|
The fear pregnant women in groups were measured and recorded prior to the intervention (when cervical dilatation reached 4-5 cm).
Assessed childbirth of fear with version A of the Wijma Delivery Expectancy.
Questionnaire score.
The minimum and maximum scores that can be obtained from the scale range between 0 and 165.
Increasing scores indicate women's fear of childbirth.
|
Baseline
|
Recurrence of Fear of Childbirth
Time Frame: 30 minutes, 60 minutes and 90 minutes
|
A 30-minute long intervention was administered in groups Dance and Music.
The fear measurements were repeated soon after the intervention, 30 minutes and 60 minutes after the intervention.
Assessed childbirth of fear with version A of the Wijma Delivery Expectancy.
Questionnaire score.
The minimum and maximum scores that can be obtained from the scale range between 0 and 165.
Increasing scores indicate women's fear of childbirth.
|
30 minutes, 60 minutes and 90 minutes
|
Recurrence of perceived pain
Time Frame: 30 minutes, 60 minutes and 90 minutes
|
Measurements were repeated 30 minutes after the first measurement, after 60 minutes, and after 90 minutes. Assessed the labor pain level with Visual Analogue Scale score. This is a 10 cm scale which is labeled "no pain" at one end and "severe pain" at the other end. (0=no pain; 10= pain as bad as can be). Increasing scores indicate women's labor pain. |
30 minutes, 60 minutes and 90 minutes
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Abdul-Sattar Khudhur Ali S, Mirkhan Ahmed H. Effect of Change in Position and Back Massage on Pain Perception during First Stage of Labor. Pain Manag Nurs. 2018 Jun;19(3):288-294. doi: 10.1016/j.pmn.2018.01.006. Epub 2018 Apr 19.
- Whitburn LY, Jones LE, Davey MA, Small R. Women's experiences of labour pain and the role of the mind: an exploratory study. Midwifery. 2014 Sep;30(9):1029-35. doi: 10.1016/j.midw.2014.04.005. Epub 2014 Apr 30.
- Simavli S, Kaygusuz I, Gumus I, Usluogullari B, Yildirim M, Kafali H. Effect of music therapy during vaginal delivery on postpartum pain relief and mental health. J Affect Disord. 2014 Mar;156:194-9. doi: 10.1016/j.jad.2013.12.027. Epub 2013 Dec 28.
- Masoudi Z, Akbarzadeh M, Vaziri F, Zare N, Ramzi M. The effects of decreasing maternal anxiety on fetal oxygenation and nucleated red blood cells count in the cord blood. Iran J Pediatr. 2014 Jun;24(3):285-92.
- Gokyildiz Surucu S, Ozturk M, Avcibay Vurgec B, Alan S, Akbas M. The effect of music on pain and anxiety of women during labour on first time pregnancy: A study from Turkey. Complement Ther Clin Pract. 2018 Feb;30:96-102. doi: 10.1016/j.ctcp.2017.12.015. Epub 2017 Dec 19.
- Abdolahian S, Ghavi F, Abdollahifard S, Sheikhan F. Effect of dance labor on the management of active phase labor pain & clients' satisfaction: a randomized controlled trial study. Glob J Health Sci. 2014 Mar 30;6(3):219-26. doi: 10.5539/gjhs.v6n3p219.
- O'Connell MA, Khashan AS, Leahy-Warren P, Stewart F, O'Neill SM. Interventions for fear of childbirth including tocophobia. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013321. doi: 10.1002/14651858.CD013321.pub2.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Study of Labor Dance and Music
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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