The Effect of Guided Imagery and Music Play on Labor Pain, Anxiety, and Birth Experience

Sponsor
Istanbul University - Cerrahpasa (IUC) (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT06035172
Collaborator
(none)
144
1
3
9
16

Study Details

Study Description

Brief Summary

Purpose: The aim of this project is to examine the effects of guided imagery and music performance during labor on labor pain, anxiety and birth experience.

Methods: The research to be carried out within the scope of the project is randomized controlled and has an experimental research design. The population of the research consists of primiparous pregnant women who applied to the Istanbul Provincial Health Directorate, Istanbul Training and Research Hospital, Suleymaniye Obstetrics and Pediatrics Additional Service Building, Birth Unit. Eligible participants in the study sample will be randomly selected at a 1:1:1 ratio. In the calculation of the sample size, using the G*Power (3.1.9.2) program, 5% first type error, 0.30 standardized effect size, distribution ratio to 1 groups, 90% power considering data loss, and the minimum sample size required for 3 groups was 144 people in total. calculated as 48 cases for each group. The group of pregnant women who meet the inclusion criteria will be determined by using the "Randomizer.org" program. In this direction, 48 people (guided imagery) should be included in experiment 1, 48 people in experiment 2 (musical concert) and 48 people in control group. "Informed Consent Form" and "Voluntary Consent Form" will be presented to the pregnant women included in the study, by giving information about the study."Personal Information Form", "Visual Analogue Scale (VAS)", "State Trait Anxiety Scale (STAI Form TX-1)" and "Birth Expectations and Experiences Scale-Part 1 (DBSS-1)" will be applied to pregnant women assigned to the Guided Imagery Group. . In the active phase of labor, when the cervical opening is measured as 4-5 cm, 6-7 cm and 8-10 cm, a 15-minute guided imagery concert (of the scenario determined for the birth process) prepared by the researchers within the scope of the literature, with the service of a ney artist and a psychological counselor, is played by bluetooth from an MP3 player. The pregnant woman will be listened to by the researcher through headphones. "VAS" will be applied after each attempt. 1 hour after the birth of the baby and placenta, data will be collected by applying "VAS", "STAI Form TX-1" and "Birth Expectations and Experiences Scale-Part 2 (DBSS-2)".

"Personal Information Form", "VAS", "STAI Form TX-1" and "DBSS-1" will be applied to pregnant women assigned to the music concert group. In the active phase of labor, when the cervical opening is measured as 4-5 cm, 6-7 cm and 8-10 cm, the 15-minute ney concert in the acemasiran tune (instrumental music), which was prepared by the researchers with the service of the ney artist within the scope of the literature (the scenario determined for the birth process), was played from the MP3 player via bluetooth headphones. The pregnant woman will be listened to by the researcher. "VAS" will be applied after each attempt. Data will be collected by applying "VAS", "STAI Form TX-1" and "DBSS-2" 1 hour after the birth of the baby and placenta.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: guided imagery
  • Behavioral: music recital
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
144 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Guided Imagery and Music Play on Labor Pain, Anxiety, and Birth Experience: A Randomized Controlled Study
Actual Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jan 31, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: guided imagery group

Behavioral: guided imagery
The guided imagery technique, which is one of these methods, is used in the method of pain by establishing a connection between mind and body. In the technique, a peaceful scene is depicted in which positive energy is reflected in the person to ensure complete relaxation and relaxation.

Experimental: music group

Behavioral: music recital
It is stated that the acemasiran tune (instrumental music) has a reducing effect on the duration of labor, as well as having labor pain and muscle relaxant properties.

No Intervention: Control group

Outcome Measures

Primary Outcome Measures

  1. Reduction of labor pain [15 minutes]

    labor pain assessed by VAS

  2. Reduction of Anxiety [15 minutes]

    anxieties of vaginal birth assessed by STAI Form TX-1

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Being between the ages of 18-35,

  • Primiparous and singleton pregnancy,

  • No risky pregnancy,

  • At 38 to 42 weeks of pregnancy,

  • Being literate and able to speak and understand Turkish,

  • Pregnant women with a cervical dilation of 4 to 5 cm.

Exclusion Criteria:
  • Being under the age of 18,

  • Presence of chronic disease,

  • Women who became pregnant as a result of the application of assisted reproductive techniques,

  • Hearing problem,

  • Having a known diagnosis of serious psychiatric illness.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Betül Uncu Istanbul Turkey 34320

Sponsors and Collaborators

  • Istanbul University - Cerrahpasa (IUC)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Betul Uncu, Principal Investigator, Istanbul University - Cerrahpasa (IUC)
ClinicalTrials.gov Identifier:
NCT06035172
Other Study ID Numbers:
  • 2022/362
First Posted:
Sep 13, 2023
Last Update Posted:
Sep 13, 2023
Last Verified:
Sep 1, 2023
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 Betul Uncu, Principal Investigator, Istanbul University - Cerrahpasa (IUC)
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 13, 2023