NCT07081789

Brief Summary

The aim of this clinical trial is to evaluate whether interventions such as listening to music and doing puzzles are effective in reducing menstrual pain, menstrual symptoms, and perceived stress in young women with dysmenorrhea, ages 18-25. The main questions it aims to answer are: Do listening to music and doing puzzles reduce dysmenorrhea pain? Do these interventions affect menstrual symptoms and perceived stress? The researchers will compare music, puzzle, and control groups to assess the effects on pain intensity, menstrual symptoms, and perceived stress levels. Participants: Participants will be followed for three menstrual cycles, In the first cycle, pain, symptoms, and stress levels will be measured, In the next two cycles: Music group: Listen to a specific song with headphones for four days, Puzzle group: Do puzzles for the same amount of time, Control group: Measurements only, without intervention.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

January 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 23, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

5 months

First QC Date

June 30, 2025

Last Update Submit

July 16, 2025

Conditions

Keywords

DysmenorrheaPainPuzzleMusicComplementary medicine

Outcome Measures

Primary Outcomes (1)

  • Menstrual Pain Severity

    Menstrual pain intensity will be assessed using the 100 mm Visual Analog Scale (VAS). Participants will rate their pain by marking a point on a 10 cm horizontal line ranging from 0 ("no pain") to 10 ("worst imaginable pain"). Higher scores indicate more severe pain.

    Through study completion, an average of 3 mounts

Secondary Outcomes (2)

  • Menstrual Symptom Severity

    Through study completion, an average of 3 mounts

  • Perceived Stress Level

    Through study completion, an average of 3 mounts

Study Arms (3)

Music Group

EXPERIMENTAL
Behavioral: Music Listening

Puzzle Group

EXPERIMENTAL
Behavioral: Puzzle Activity

Control Group

NO INTERVENTION

No intervention.

Interventions

Music ListeningBEHAVIORAL

Participants will listen to a 24 min 54 sec music track for 4 days (starting 3 days before menstruation).

Music Group
Puzzle ActivityBEHAVIORAL

Participants will do puzzles for the same duration and timing.

Puzzle Group

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female students studying at a university health college
  • Female students between the ages of 18 and 25
  • Female students with a Visual Analog Scale (100 mmVAS) pain intensity of 5 or higher
  • Female students with regular menstrual cycles (28 ± 7 days) within the past year
  • Female students without endocrine, neurological, or chronic diseases such as pelvic pathology, hearing loss, diabetes, and heart disease
  • Female students without psychiatric illnesses or mental health problems that would interfere with evaluation and cooperation
  • Female students who are not using oral contraceptives or antidepressants
  • Female students who have not had pelvic surgery
  • Female students who have not had malignant diseases
  • Female students who are not obese
  • Female students who have not previously been pregnant
  • Female students who have not received advanced musical training
  • Female students who are not taking vitamin supplements

You may not qualify if:

  • Female students who use medication, non-drug practices (acupressure, Reiki, reflexology, meditation), or any nutritional supplements to reduce pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bucak Health School

Burdur, Bucak, Turkey (Türkiye)

Location

Related Publications (4)

  • Martin-Saavedra JS, Ruiz-Sternberg AM. The effects of music listening on the management of pain in primary dysmenorrhea: a randomized controlled clinical trial. Nordic J Music Therapy. 2020;29(5):398-415. https://doi.org/10.1080/08098131.2020.1761867.

    BACKGROUND
  • Selçuk AK, Baysal E. The effect of dark chocolate and music on pain and anxiety in young women with primary dysmenorrhea: Randomized controlled trial. Eur J Integr Med. 2022;56:102192. https://doi.org/10.1016/j.eujim.2022.102192.

    BACKGROUND
  • Ferries-Rowe E, Corey E, Archer JS. Primary Dysmenorrhea: Diagnosis and Therapy. Obstet Gynecol. 2020 Nov;136(5):1047-1058. doi: 10.1097/AOG.0000000000004096.

    PMID: 33030880BACKGROUND
  • Hu Z, Tang L, Chen L, Kaminga AC, Xu H. Prevalence and Risk Factors Associated with Primary Dysmenorrhea among Chinese Female University Students: A Cross-sectional Study. J Pediatr Adolesc Gynecol. 2020 Feb;33(1):15-22. doi: 10.1016/j.jpag.2019.09.004. Epub 2019 Sep 17.

    PMID: 31539615BACKGROUND

MeSH Terms

Conditions

DysmenorrheaPain

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Endam Çetinkaya Ak, Assistant Professor

    Burdur Mehmet Akif Ersoy University

    PRINCIPAL INVESTIGATOR

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
Assistant Professor

Study Record Dates

First Submitted

June 30, 2025

First Posted

July 23, 2025

Study Start

January 1, 2025

Primary Completion

June 1, 2025

Study Completion

August 30, 2025

Last Updated

July 23, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Individual Participant Data (IPD) will not be shared due to ethical considerations and privacy concerns. The dataset includes sensitive health information, and no data sharing agreements are in place to ensure appropriate secondary use.

Locations