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

NCT ID: NCT06035172

Last Updated: 2024-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Labor Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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guided imagery group

Group Type EXPERIMENTAL

guided imagery

Intervention Type BEHAVIORAL

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 group

Group Type EXPERIMENTAL

music recital

Intervention Type BEHAVIORAL

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.

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

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Betul Uncu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Betül Uncu

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 33886910 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35515089 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29589650 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30675962 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33655203 (View on PubMed)

Other Identifiers

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2022/362

Identifier Type: -

Identifier Source: org_study_id

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