The Effect of Music on Pain, Anxiety and Satisfaction During Intrauterine Device Application

NCT06215183 | Completed

• 1 other identifier: SKOSE
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This study was planned to determine the effect of music listened to during intrauterine device application on pain,anxiety and satisfaction.

Conditions

Reproductive Health; Pain; Women Health

Keywords

Intrauterine device; Pain; Anxiety; Satisfaction

Outcome Measures

Primary Outcomes (2)

• Anxiety

  Data will be collected using the State Anxiety Inventory. The answer options collected in four classes on the State Anxiety Inventory scale are: (1) Not at all, (2) A little, (3) A lot and (4) Completely; The options on the trait anxiety scale are (1) Rarel, (2) Sometimes, (3) A lot of the time, and (4) Almost always. The higher the score obtained from the scales, the higher the person's anxiety is. The total score obtained from the scale varies between 20-80, and 20-39 indicates a mild anxiety level, 40-59 indicates a medium anxiety level, 60-79 indicates a high anxiety level, and 80 points indicates a panic anxiety level.

  30 minütes

• Pain Level

  Data will be collected using the Visual Analogue Scale. Pain can be given a score between 0 and 10 on the scale.The higher the scale score, the greater the pain.

  30 minütes

Secondary Outcomes (1)

• Satisfaction Level

  30 minütes

Study Arms (2)

Intervention Group

EXPERIMENTAL

Women in the intervention group applying for IUD application will listen to music for 5 minutes before, during and after the procedure.

Other: Music therapy

Control Group

NO INTERVENTION

Women in the control group applying for IUD application will not be subjected to any intervention other than routine IUD insertion procedures.

Interventions

Music therapy OTHER

Women applying for IUD application will receive music therapy for 5 minutes before the procedure, during the IUD application, and for 5 minutes after the procedure.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Knowing how to read and write,
• Not having had an IUD inserted before,
• Being between the ages of 18-49,
• No hearing-related problems,
• Not having used analgesic or anesthetic medication within 24 hours before or during the procedure,
• Voluntarily participating in the study,

You may not qualify if:

• The woman has a cognitive and auditory problem
• Having a history of cervical surgery

Sponsors & Collaborators

• Sümeyye Köse: lead

Study Sites (1)

Pendik District Health Directorate Maternal Child Health and Family Planning Center

Istanbul, Pendik, 34890, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders; Personal Satisfaction

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The evaluation was made by the participants in the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Phd Student

Model Details: The study is a randomized controlled trial.

Study Record Dates

• First Submitted: January 7, 2024
• First Posted: January 22, 2024
• Study Start: January 1, 2024
• Primary Completion: June 30, 2024
• Study Completion: July 30, 2024
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)