Clinical trial NCT06838936: Binaural Beats Dysmenorrhea And Sleep Quality
Official title: The Effect of Binaural Beats on Sleep Quality and Dysmenorrhea During Menstruation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dysmenorrhea Primary
Keywords: dysmenorrhea primary
pain
sleep quality
binaural beats
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Our study has two groups of 60 participiants each group. Our study is an experimental study with pretest-posttest control group.
Primary purpose: SUPPORTIVE_CARE

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.

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
* 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.

Primary outcomes:
measure: Numeric Rating Scale
timeFrame: up to six months
measure: Menstrual Symptom Questionnaire
timeFrame: up to six months
measure: Pittsburgh Sleep Quality Index
timeFrame: up to six months
measure: Women's Health Initiative Insomnia Scale
timeFrame: up to six months
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu University
city: Malatya
country: Turkey
facility: Inonu University
Study officials:
References: