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Completed

NCT Number: NCT06838936

Binaural Beats Dysmenorrhea And Sleep Quality

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.

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Key information

Conditions

Dysmenorrhea Primary Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Inonu University

Malatya, 44280, Turkey (Türkiye)

About this study

Binaural beats are based on creating a physiological response by applying sound at different frequencies to both ears. The brain perceives the sound given at different frequencies to both ears as a single frequency. The perception of different frequency sounds as a single frequency is called binaural integration. EEG studies suggest that binaural beats can affect electrocortical activity; that is, they can modulate the frequency of neuronal oscillations without requiring prior training. Binaural beats application reduces pain, anxiety, and stress and improves sleep quality in individuals. Binaural beats is a non-pharmacological application that does not require any training before application. No side effects have been reported in the studies conducted in the literature, and it is also emphasized that it is an effective, cheap, safe, and non-pharmacological application. From this point of view, this study aims to determine the effect of binaural beats on sleep quality and dysmenorrhea during menstruation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Not having alcohol or substance addiction constitutes the inclusion criteria of the study.

Exclusion criteria

  • 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
  • Experiencing irregular menstrual bleeding in the last three months constitutes the study's exclusion criteria.

Treatment and study plan

Binaural Beats

Other

Mobile application for binaural beats listening

Primary outcomes

  1. Numeric Rating Scale

    Time frame: up to six months

    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.

  2. Menstrual Symptom Questionnaire

    Time frame: up to six months

    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.

  3. Pittsburgh Sleep Quality Index

    Time frame: up to six months

    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.

  4. Women's Health Initiative Insomnia Scale

    Time frame: up to six months

    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.

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

The Effect of Binaural Beats on Sleep Quality and Dysmenorrhea During Menstruation

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2025
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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