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

Labor Pain Clinical Trial

Official title:

The Effect of Guided Imagery and Music Play on Labor Pain, Anxiety, and Birth Experience: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06035172
• Other study ID #: 2022/362
• Status: Completed
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: May 2024
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Labor Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Betül Uncu	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of labor pain	labor pain assessed by VAS	15 minutes
Primary	Reduction of Anxiety	anxieties of vaginal birth assessed by STAI Form TX-1	15 minutes