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Effect of Labor Dance and Music on Labor Pain and Fear of Childbirth

Primary Purpose

Labor Pain, Fear of Childbirth

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Labor dance
Music
Sponsored by
Ankara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Labor Pain focused on measuring Labor Pain, Labor dance, Music, Fear of childbirth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. An indication for vaginal delivery
  2. Primipara
  3. Cervical dilatation of 3 cm or over
  4. Full-term pregnancy (38-42 gestational weeks)
  5. Single healthy fetus in vertex position
  6. No complication that can cause dystocia in labor (such as contraction anomalies, birth object, birth canal associated dystocia, maternal psychology associated dystocia)
  7. Not using analgesia and anesthesia during the first phase of the labor
  8. Having no physical disability to dance
  9. Having no difficulty to take upright position and move
  10. Having no communication problem.

Exclusion Criteria:

  1. Giving up participating in the study
  2. Abnormal changes in fetal heartbeat
  3. 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.

Sites / Locations

  • Ankara University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Labor Dance and music groups

Control group

Arm Description

Labor Dance; 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 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.

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.

Outcomes

Primary Outcome Measures

Visual Analogue Scale Score,
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.

Secondary Outcome Measures

Version A of the Wijma Delivery Expectancy Questionnaire Score
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.
Recurrence of Fear of Childbirth
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.
Recurrence of perceived pain
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.

Full Information

First Posted
August 17, 2018
Last Updated
August 23, 2018
Sponsor
Ankara University
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1. Study Identification

Unique Protocol Identification Number
NCT03648099
Brief Title
Effect of Labor Dance and Music on Labor Pain and Fear of Childbirth
Official Title
Effect of Labor Dance and Music on Labor Pain and Fear of Childbirth
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 15, 2018 (Actual)
Primary Completion Date
June 15, 2018 (Actual)
Study Completion Date
June 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study was conducted to investigate the effect of labor dance and music used during the active phase of labor on labor pain and fear of childbirth. The study was designed as a single-blind randomized controlled intervention trial. The participants included in sample are taken into 3 groups (totally 93 participants). A total of 93 individuals, 31 of whom were in the dance group (D), 30 in the music group (M), and 32 in the control group (C), were included in the survey. Data were collected between 15 February 2018 and 15 June 2018 by means of a Personal Information Form, the Labor Monitoring Form, the Visual Analogue Scale (VAS), and version A of the Wijma Delivery Expectancy Questionnaire (W-DEQA).
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain, Fear of Childbirth
Keywords
Labor Pain, Labor dance, Music, Fear of childbirth

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
a single-blind randomized controlled intervention trial
Masking
Care Provider
Masking Description
In order to avoid bias in assessing pain and fear, three midwives who were not involved in the study team, who worked in the hospital where the study was carried out and who did not know the groups of the participants administered the scales. The midwives who were involved in data collection during the study were trained by the researchers on the use of data collection tools.
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Labor Dance and music groups
Arm Type
Experimental
Arm Description
Labor Dance; 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 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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Labor dance
Intervention Description
The dance group which involved pregnant women who performed the labor dance
Intervention Type
Behavioral
Intervention Name(s)
Music
Intervention Description
The music group involving pregnant women who were exposed to music.
Primary Outcome Measure Information:
Title
Visual Analogue Scale Score,
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Version A of the Wijma Delivery Expectancy Questionnaire Score
Description
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.
Time Frame
Baseline
Title
Recurrence of Fear of Childbirth
Description
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.
Time Frame
30 minutes, 60 minutes and 90 minutes
Title
Recurrence of perceived pain
Description
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.
Time Frame
30 minutes, 60 minutes and 90 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Ankara University
City
Altındağ
State/Province
Ankara
ZIP/Postal Code
06340
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29680213
Citation
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.
Results Reference
background
PubMed Identifier
24820004
Citation
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.
Results Reference
result
PubMed Identifier
24411681
Citation
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.
Results Reference
result
PubMed Identifier
25562022
Citation
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.
Results Reference
result
PubMed Identifier
29389487
Citation
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.
Results Reference
result
PubMed Identifier
24762366
Citation
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.
Results Reference
result
PubMed Identifier
34231203
Citation
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.
Results Reference
derived

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Effect of Labor Dance and Music on Labor Pain and Fear of Childbirth

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