Dysmenorrhea PrimaryNCT06838936
Binaural Beats Dysmenorrhea And Sleep Quality
A study testing Binaural Beats in people with Dysmenorrhea Primary, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dysmenorrhea Primary
- What is being tested?
- Binaural Beats
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2024to 15 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Binaural Beats
- Keywords
- dysmenorrhea primary, pain, sleep quality, binaural beats
- Medical subject headings
- Pain, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Binaural BeatsOther
Mobile application for binaural beats listening
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Mobil application (binaural beats) Receives: Other: Binaural Beats |
| Control group | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start30 Nov 2024
- Primary completion30 Jan 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysmenorrhea PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Our study has two groups of 60 participiants each group. Our study is an experimental study with pretest-posttest control group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Hazar, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838936
- Sponsor's protocol ID
- Nursing Department
- Status last verified
- Jun 2025
- First submitted
- 19 Jan 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Indivual participant data (IPD) will not be avaliable to other researchers, they will be kept secret.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Binaural Beats on Sleep Quality and Dysmenorrhea During Menstruation
- ClinicalTrials.gov ID
- NCT06838936
- Acronym / sponsor ID
- Nursing Department
- Conditions
- Dysmenorrhea Primary
- Keywords
- dysmenorrhea primary, pain, sleep quality, binaural beats
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 30 Nov 2024 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Our study has two groups of 60 participiants each group. Our study is an experimental study with pretest-posttest control group.
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Other: Binaural BeatsMobil application (binaural beats) |
| Control group | No intervention | –Control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Binaural BeatsMobile application for binaural beats listening | Other | Interventional group |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No. Indivual participant data (IPD) will not be avaliable to other researchers, they will be kept secret.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Binaural Beats in people with Dysmenorrhea Primary, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (time frame: up to six months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.