The Effect of Interactive Music Therapy Applied to Women During the Perioperative Period for IVF on Their Stress Levels

Sponsor
Uludag University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT06117202
Collaborator
(none)
240
1
2
21
11.4

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the effect of music therapy on stress levels in female patients applying for in vitro fertilization.

Condition or Disease Intervention/Treatment Phase
  • Other: music therapy
N/A

Detailed Description

If the patients participate in the study, when they apply to the in vitro fertilization center, they will meet with their anesthesiologist, anesthesia assessment will be done face to face and asked some questions about the diseases that may affect the procedure. . If patients are included in the study, their blood pressure, blood oxygen value and heart rate will be measured and recorded, as in every patient. Subsequently, a test will be administered to assess stress and anxiety levels of the patients. The patients involved in the study will be randomly divided into two groups. One group will be provided with a set of headphones that completely cover the ears and will be played their selected music from a predetermined album for 20 minutes before the procedure. The music will continue to be played through the headphones during the procedure. The other group will be taken to the operating room without any procedure, and this process will be applied to both groups. When patients are brought to the operating room, blood pressure, blood oxygen levels, and heart rate will be measured and recorded once again. Routine anesthesia procedures, applicable to all, will be carried out. After patients are fully awake, their pain condition will be assessed using a visual test.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of Interactive Music Therapy Applied to Women During the Perioperative Period for In Vitro Fertilization(IVF) on Their Stress Levels
Actual Study Start Date :
Aug 17, 2023
Anticipated Primary Completion Date :
Mar 18, 2025
Anticipated Study Completion Date :
May 18, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: music therapy

The patients involved in the study will be randomly divided into two groups. One group will be provided with a set of headphones that completely cover the ears and will be played their selected music from a predetermined album for 20 minutes before the procedure. The music will continue to be played through the headphones during the procedure.

Other: music therapy
The research is a thesis study aimed at determining the stress and anxiety levels of patients seeking in vitro fertilization, investigating influencing factors, and revealing the impact of pre-procedural music listening on these stress and anxiety levels.

No Intervention: control group

The control group will be taken to the operating room with standard anesthesia care protocol.

Outcome Measures

Primary Outcome Measures

  1. stress,anxiety levels [30 minutes]

    The stress levels of the participants will be assessed using the State-Trait Anxiety Inventory scale. The obtained scores theoretically range between 20 and 80. A high score represents a high level of anxiety, while a low score indicates a low level of anxiety.

Secondary Outcome Measures

  1. Postoperative pain level [30 minutes]

    The participants' pain levels will be assessed using the Visual Analog Scale (0-10 point). A score of zero on this scale represents a pain-free condition for the patient, while the highest score reflects the most severe pain they have experienced in their life.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 18 years and older,

  • American Society of Anesthesiologists (ASA) scores I-III.

Exclusion Criteria:
  • Patients who did not provide informed consent,

  • Used anxiolytics, alcohol, or drugs before the procedure,

  • Refused to participate in the study,

  • Lost their hearing ability for any reason.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Uludag University Bursa Turkey 16059

Sponsors and Collaborators

  • Uludag University

Investigators

  • Study Director: Selcan AKESEN, Uludag University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gizem Nur BAYRAM, research assistant doctor, Uludag University
ClinicalTrials.gov Identifier:
NCT06117202
Other Study ID Numbers:
  • Uludag University1
First Posted:
Nov 3, 2023
Last Update Posted:
Nov 8, 2023
Last Verified:
Nov 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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 8, 2023