NCT07633990

Brief Summary

The aim of this study is to determine whether a video viewed through virtual reality goggles accompanied by music has an effect on pain and sleep quality in women with dysmenorrhea. The main questions it seeks to answer are as follows:

  • Does watching a video through virtual reality goggles accompanied by music reduce pain in women with dysmenorrhea?
  • Does watching a video through virtual reality goggles accompanied by music improve sleep quality in women with dysmenorrhea? The study will compare a group that uses music from the virtual reality video with another group to determine whether the virtual reality application has an effect on pain and sleep quality. Participants will do the following: For 3 days, use the virtual reality or music application every evening before going to bed after completing the VAS. The next day, after waking up, complete the VAS and the sleep quality scale and record the results.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2023

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

April 7, 2026

Last Update Submit

June 3, 2026

Conditions

Keywords

DysmenorrheaVirtual RealityMusicPainSleep Quality

Outcome Measures

Primary Outcomes (1)

  • Distribution of women according to the characteristics of their menstrual cycles

    This table includes the latest menstrual pain scale, the occurrence of pain during the menstrual cycle, the type of dysmenorrhea, the timing of dysmenorrhea, information about menstruation, who provided information about menstruation, the use of pain relievers during the menstrual period, non-pharmacological interventions used to alleviate menstrual pain, non-pharmacological interventions used to alleviate menstrual pain, the presence of dysmenorrhea in the family, and gynecological diagnosis data. Patients with a pain scale (VAS) score of 4 or higher were evaluated, and the analysis proceeded to secondary outcomes.

    4 weeks

Secondary Outcomes (6)

  • Comparison of Participants' Sociodemographic Characteristics by Group

    2 weeks

  • A Comparison of Certain Characteristics of Participants' Menstrual Cycles Across Groups

    4 weeks

  • Comparison of Dysmenorrhea Characteristics Among Participants by Group

    4 weeks

  • Comparison of Participants' Sleep-Related Characteristics by Group

    4 weeks

  • Comparisons of Participants' Visual Analog Scale (VAS) Scores Between and Within Groups

    6 weeks

  • +1 more secondary outcomes

Study Arms (2)

experiment

EXPERIMENTAL

Group shown a video using a virtual reality headset: For this experiment, a video featuring nature scenes and waterfalls was downloaded to a phone, loaded into a virtual reality headset, and provided to the participant ready for use.

Other: experiment

control

PLACEBO COMPARATOR

Unlike the intervention group, the women in the control group were given MP3 players by the researcher, instructed on how to use them, and had the music used in the virtual reality video loaded onto the devices for them to listen to.

Other: Control

Interventions

Group shown a video using a virtual reality headset: A video containing images of nature and waterfalls is downloaded to a phone and provided to the participant ready to use inside a virtual reality headset; the procedure is carried out as described below. For three consecutive days, each day: * After menstruation begins, apply the VAS pain scale before going to bed in the evening * In the evening, in a dark and quiet environment, watch the 30-minute virtual reality video as instructed by the researcher until falling asleep * The following morning, apply the VAS pain scale and RCUÖ and inform the researcher. After the study was completed, the equipment returned to the researcher was calibrated and cleaned as necessary by the researcher and prepared for use with another patient.

Also known as: Virtual Reality
experiment
ControlOTHER

Unlike the intervention group, the women in the control group were given an MP3 player by the researcher, instructed on how to use it, and had the music used in the virtual reality video loaded onto it for them to listen to. For three consecutive days, each day: * Apply the VAS pain scale in the evening before going to bed after menstruation has occurred * Listen to the 30-minute music in a dark and quiet environment in the evening, as instructed by the researcher * Apply the VAS pain scale and RCUÖ the following morning and inform the researcher. After the study was completed, the equipment returned to the researcher was calibrated and cleaned as necessary by the researcher and prepared for use with another patient.

Also known as: music
control

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Women who volunteered to participate in the study,
  • Who are at least literate,
  • Aged 15-49 and not yet in menopause,
  • Who are not pregnant,
  • Who have been diagnosed with dysmenorrhea by a physician and have a pain intensity of at least 4 on the Visual Analogue Scale

You may not qualify if:

  • Women with dysmenorrhea pain intensity below 4 on the Visual Analog Scale,
  • Women with vision or hearing impairments,
  • Women who are unwilling to participate in the study,
  • Women using analgesic medications for menstrual pain,
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baykan State Hospital

Siirt, Baykan, 56460, Turkey (Türkiye)

Location

MeSH Terms

Conditions

DysmenorrheaPainSleep Initiation and Maintenance Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainNeurologic ManifestationsSigns and SymptomsSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Remzi KARASUNGUR

    not affiliated

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

April 7, 2026

First Posted

June 8, 2026

Study Start

January 5, 2023

Primary Completion

March 29, 2023

Study Completion

September 24, 2023

Last Updated

June 8, 2026

Record last verified: 2026-06

Locations