Binaural Beats Dysmenorrhea And Sleep Quality

NCT ID: NCT06838936

Last Updated: 2025-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2025-05-15

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.

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.

Conditions

Dysmenorrhea Primary

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Interventional group

Mobil application (binaural beats)

Group Type: EXPERIMENTAL

Binaural Beats

Intervention Type: OTHER

Mobile application for binaural beats listening

Control group

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Binaural Beats

Mobile application for binaural beats listening

Intervention Type: OTHER

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Inonu University

OTHER

Sponsor Role: lead

Responsible Party

Seda Hazar

Research assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Inonu University

Malatya, Malatya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Nursing Department

Identifier Type: -

Identifier Source: org_study_id