Binaural Beats Dysmenorrhea And Sleep Quality

NCT06838936 | Completed DMC

• 1 other identifier: Nursing Department
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The research is a randomized controlled trial. The sample group will consist of 120 people; 60 participants will be included in the experimental group, and 60 will be included in the control group. In the study, the participants in the experimental group will listen to the alpha sound for pain for 10 minutes and the delta sound for sleep for 15 minutes via the mobile application three days a week. The researchers will not intervene with the control group during the study. During the study, only the data collection tabs of the mobile application will be active for the control group, and the use of the sounds will be opened at the end of the study. The study data were used in the personal identification form, menstruation symptom scale, Pittsburgh sleep quality index, and Women's Health Initiative Insomnia Scale.

Conditions

Dysmenorrhea Primary

Keywords

dysmenorrhea primary; pain; sleep quality; binaural beats

Outcome Measures

Primary Outcomes (4)

• Numeric Rating Scale

  The Numerical Pain Scale is the most commonly used and easiest to measure scale for pain assessment. No pain is given 0 (zero), and unbearable pain is given 10 (ten) points.

  up to six months

• Menstrual Symptom Questionnaire

  It was developed by Chesney and Tasto in 1975 to assess menstrual pain and symptoms. The scale, which is a five-point Likert type and consists of 24 items, was updated by Negriff et al. in 2009. The MSÖ score is calculated by taking the total score average of the items in the scale. An increase in the score average indicates that the severity of menstrual symptoms increases. The scale consists of 22 items and a total of three sub-dimensions. On the scale, participants give a value between one and five (1=never, 2=sometimes, 3=occasionally, 4=often, 5=always) to the symptoms they experience related to menstruation. The score obtained from the sub-dimensions in the scale is calculated by taking the total score average of the items in the sub-dimensions. An increase in the scoring average for the sub-dimensions indicates that the severity of menstrual symptoms related to that sub-dimension increases.

  up to six months

• Pittsburgh Sleep Quality Index

  The Pittsburgh Sleep Quality Index was developed in 1988 to determine sleep quality. It consists of 7 components with a total of 24 questions. These components are subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, use of sleeping pills and daytime dysfunction. The sum of the scores of all components gives the PSQI score. The 10th and 11th questions in the index are not included in the calculation. Scores of 5 and above indicate poor sleep quality, and as the score received on the scale increases, sleep quality worsens. The index was studied for reliability and validity by Ağargün et al (1996) and its internal consistency was found to be 0.80.

  up to six months

• Women's Health Initiative Insomnia Scale

  The validity and reliability study of the scale developed by Levine et al. (2003) was conducted in our country by Timur and Şahin (2009). The scale is a Likert-type scale consisting of 5 questions. The first four questions in the scale determine the onset of insomnia, inability to maintain sleep, and early morning awakening. The last question is related to sleep quality. The answer to each question is based on the individual's experiences in the last 4 weeks and considering the frequency of each week.

  up to six months

Study Arms (2)

Interventional group

EXPERIMENTAL

Mobil application (binaural beats)

Other: Binaural Beats

Control group

NO INTERVENTION

Control group

Interventions

Binaural Beats OTHER

Mobile application for binaural beats listening

Interventional group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women with primary dysmenorrhea
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being over 18 years old
• Having headphones (for the experimental group)
• Having pain of 4 and above according to the numerical pain scale
• Taking a Women's Health and Diseases Nursing Course
• Not using medication during menstruation
• Not using sleeping pills
• Being single
• Not using contraceptives
• Not having a hearing problem
• Not having a psychiatric problem

You may not qualify if:

• Not listening to binaural sounds for two days or more on the days specified in the mobile application
• Using analgesics during menstruation while the study is ongoing

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu University

Malatya, Malatya, 44280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be determined blindly by being assigned by a site
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Model Details: Our study has two groups of 60 participiants each group. Our study is an experimental study with pretest-posttest control group.

Study Record Dates

• First Submitted: January 19, 2025
• First Posted: February 21, 2025
• Study Start: November 30, 2024
• Primary Completion: January 30, 2025
• Study Completion: May 15, 2025
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)