NCT06035172

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

October 28, 2024

Status Verified

May 1, 2024

Enrollment Period

1.1 years

First QC Date

July 11, 2023

Last Update Submit

October 24, 2024

Conditions

Keywords

Birth painmusic listeningpositive birthguided imagery

Outcome Measures

Primary Outcomes (2)

  • Reduction of labor pain

    labor pain assessed by VAS

    15 minutes

  • Reduction of Anxiety

    anxieties of vaginal birth assessed by STAI Form TX-1

    15 minutes

Study Arms (3)

guided imagery group

EXPERIMENTAL
Behavioral: guided imagery

music group

EXPERIMENTAL
Behavioral: music recital

Control group

NO INTERVENTION

Interventions

guided imageryBEHAVIORAL

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.

guided imagery group
music recitalBEHAVIORAL

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.

music group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Betül Uncu

Istanbul, 34320, Turkey (Türkiye)

Location

Related Publications (5)

  • Biana CB, Cecagno D, Porto AR, Cecagno S, Marques VA, Soares MC. Non-pharmacological therapies applied in pregnancy and labor: an integrative review. Rev Esc Enferm USP. 2021 Apr 16;55:e03681. doi: 10.1590/S1980-220X2019019703681. eCollection 2021. English, Portuguese.

    PMID: 33886910BACKGROUND
  • Rantala A, Hakala M, Polkki T. Women's perceptions of the pain assessment and non-pharmacological pain relief methods used during labor: A cross-sectional survey. Eur J Midwifery. 2022 Apr 13;6:21. doi: 10.18332/ejm/146136. eCollection 2022.

    PMID: 35515089BACKGROUND
  • Smith CA, Levett KM, Collins CT, Armour M, Dahlen HG, Suganuma M. Relaxation techniques for pain management in labour. Cochrane Database Syst Rev. 2018 Mar 28;3(3):CD009514. doi: 10.1002/14651858.CD009514.pub2.

    PMID: 29589650BACKGROUND
  • Mirghafourvand M, Mohammad Alizadeh Charandabi S, Ghanbari-Homayi S, Jahangiry L, Nahaee J, Hadian T. Effect of birth plans on childbirth experience: A systematic review. Int J Nurs Pract. 2019 Aug;25(4):e12722. doi: 10.1111/ijn.12722. Epub 2019 Jan 24.

    PMID: 30675962BACKGROUND
  • Kacar N, Ozcan Keser N. Comparison of the effect of mechanical massage and warm mechanical massage application on perceived labor pain and childbirth experience: A randomized clinical trial. Eur J Midwifery. 2021 Feb 27;5:5. doi: 10.18332/ejm/132883. eCollection 2021.

    PMID: 33655203BACKGROUND

MeSH Terms

Conditions

Labor Pain

Interventions

Imagery, Psychotherapy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 11, 2023

First Posted

September 13, 2023

Study Start

March 1, 2023

Primary Completion

March 31, 2024

Study Completion

March 31, 2024

Last Updated

October 28, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations