Binaural Beats Dysmenorrhea And Sleep Quality

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

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.

Study Overview

• Status: Completed
• Conditions: Dysmenorrhea Primary
• Intervention / Treatment: Other: Binaural Beats

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Malatya, Turkey, 44280
    • Inonu University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Experimental: Interventional group; Mobil application (binaural beats)	Other: Binaural Beats; Mobile application for binaural beats listening

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Inonu University

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2024
• Primary Completion (Actual): January 30, 2025
• Study Completion (Actual): May 15, 2025

Study Registration Dates

• First Submitted: January 19, 2025
• First Submitted That Met QC Criteria: February 20, 2025
• First Posted (Actual): February 21, 2025

Study Record Updates

• Last Update Posted (Estimated): July 1, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: pain; sleep quality; binaural beats; dysmenorrhea primary
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathologic Processes; Pelvic Pain; Menstruation Disturbances; Dysmenorrhea
• Other Study ID Numbers: Nursing Department

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Indivual participant data (IPD) will not be avaliable to other researchers, they will be kept secret.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No