Primary DysmenorrheaNCT05686460
Effect of Hegu Point Ice Massage and Music in Dysmenorrhea
A study testing ice massage and music medicine in people with Primary Dysmenorrhea, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
Trial summary
Dysmenorrhea, a gynecological health problem that is frequently observed in adolescents and young adult women and often cannot be diagnosed is defined as pelvic pain associated with menstruation. Read more about this study
- Who is it for?
- Ages 18 to 33 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- ice massage and music medicine
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2021to 30 Jun 2022
- 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 to 33 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Having menstruation regularly (between 21 and 35 days),
- Not using traditional and complementary treatments such as analgesics or massage during the application,
- Not having a diagnosed psychiatric problem and a history of endometriosis in the past,
- Not having infection and ovarian cyst / tumor, not having a neuropathic problem that might cause diabetes or nerve damage,
- Being over 18 years of age and agreeing to participate in the study.
Who cannot join
- Having hearing problems,
- Having connective tissue diseases,
- Having bleeding and coagulation disorders,
- Having fractures in the hand and arm to undergo therapy,
- Having sensitivity to cold,
- Using oral contraceptives.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effect of Hegu Point Ice Massage and Music on Pain and Comfort Levels in Dysmenorrhea
Dysmenorrhea, a gynecological health problem that is frequently observed in adolescents and young adult women and often cannot be diagnosed is defined as pelvic pain associated with menstruation.
Providing analgesia without using pharmacological treatment is the leading aim of health care and can reduce drug-related complications. Therefore, nurses' awareness of the use of complementary and alternative medicine should be raised and the methods used should be based on evidence. Our search for studies in which the effects of listening to music and ice massage applied to the Hegu point on pain management in individuals with dysmenorrhea were investigated demonstrated that the number of such studies in the literature is not many. We think that the present study is important in terms of increasing the comfort levels of individuals with dysmenorrhea, basing the applications on evidence and contributing to the literature. It was conducted to compare the effects of ice massage applied to the Hegu point and music on pain and comfort levels in nursing students with dysmenorrhea.
Read the detailed description
Dysmenorrhea, a gynecological health problem that is frequently observed in adolescents and young adult women and often cannot be diagnosed, is defined as pelvic pain associated with menstruation. The prevalence of dysmenorrhea is reported to vary between 50% and 90% in women of reproductive age. Dysmenorrhea and the symptoms accompanying dysmenorrhea cause significant economic losses by leading to both work and school absenteeism. Particularly in adolescents, due to dysmenorrhea, participation in sports and social activities is restricted, indicators of academic performance such as school absenteeism, school success, concentration, productivity are negatively affected, and thus their levels of general comfort and quality of life decrease. On the other hand, pharmacological treatment options used in the treatment of dysmenorrhea are very few. On top of this, the effectiveness of these treatment options is still debated. Since the medication used in the pharmacological treatment of dysmenorrhea has various side effects, using non-pharmacological treatments in addition to pharmacological treatment in the management of dysmenorrhea would be beneficial.
Cold application is one of the effective, simple, inexpensive and reliable non-pharmacological methods used to reduce pain, with few complications or no side effects. The Hegu point, the most important pain relief point of the body, can be stimulated in all painful conditions. Another low-risk and low-cost nonpharmacological method for standard care used in pain management is the music medicine.
This randomized clinical trial was designed to determine the effects of ice massage applied to the Hegu point and music on dysmenorrhea, compared to a control group that no intervention in women of 18 years or older from the the Faculty of Health Sciences at the Manisa Celal Bayar University, Manisa, Turkey.
- Conditions
- Primary Dysmenorrhea
- Being tested
- ice massage, music medicine
- Keywords
- comfort, ice massage, music, pain, dysmenorrhea
- Medical subject headings
- Pain, Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ice massageBehavioural
After the students who met the sample selection criteria applied Student Information Form. On the first day of the participating students' menstruation, prior to the application (when the pain started), the Visual Analogue Scale (VAS), General Comfort Questionnaire (GCQ) and Dysmenorrhea Follow-up Form were filled in at the pre-test. The Hegu point of the participating students was detected with the acupuncture point finder. Ice cubes whose dimensions were 2x2x2 cm were wrapped with gauze and placed in a plastic bag. Vaseline® jelly was spread on the application area. The application applied 2 minutes of ice massage 7 times at 15-second intervals. The participants' pain levels were assessed three times, as soon as the application was over, 30 and 60 minutes after the application (Post-test).
On the second day of menstruation, the participants were asked to fill in the VAS, GCQ, and Effects of Dysmenorrhea Scale (EDS).
music medicineBehavioural
After the students who met the sample selection criteria applied Student Information Form. On the first day of the participating students' menstruation, prior to the application (when the pain started), the Visual Analogue Scale (VAS), General Comfort Questionnaire (GCQ) and Dysmenorrhea Follow-up Form were filled in at the pre-test. Depending on their preference, each participant wearing personalized headphones was played instrumental music in the pre-menstruation period for 30 minutes. The volume of the music was adjusted based on the verbal feedback or facial expressions of the students. The participants' pain levels were assessed three times, as soon as the application was over, 30 and 60 minutes after the application (Post-test). On the second day of menstruation, the participants were asked to fill in the VAS, GCQ, and Effects of Dysmenorrhea Scale (EDS).
| Study group | Role | What they receive |
|---|---|---|
| ice massage | Experimental | The application applied 2 minutes of ice massage 7 times at 15-second intervals. The procedure was performed once on the first day and once on the second day of menstruation. Receives: Behavioral: ice massage |
| music medicine | Experimental | Depending on their preference, each participant wearing personalized headphones was played instrumental music in the pre-menstruation period for 30 minutes. The procedure was performed once on the first day and once on the second day of menstruation. Receives: Behavioral: music medicine |
| control | No intervention | On the first and second days of menstruation, their pain levels of were assessed 4 times: when the pain started (pre-test), and then 30, 60 and 90 minutes after the pain started. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questions about the menstrual characteristics of the students were asked using the Dysmenorrhea identification form
Questions about the menstrual characteristics of the students were asked using the Dysmenorrhea identification form developed by the researchers in line with the literature.
Measured: It took approximately 5-10 minutes to fill out the form.
The intensity of pain experienced during the last menstrual period was asked using the Visual Analogue Scale (VAS
The intensity of pain experienced during the last menstrual period was asked using the Visual Analogue Scale (VAS). The highest pain score that can be obtained on the Visual Analogue Scale is 10 and the lowest is 0. The higher the score, the higher the pain intensity.
Measured: It took approximately 5-10 minutes to fill out the form.
To evaluate dysmenorrhea severity using Functional and Emotional Dysmenorrhea Scale.
We asked them to determine the emotions they experienced on the first day of menstruation in accordance with the Functional and Emotional Dysmenorrhea Scale developed by Li et al. The minimum and maximum possible scores to be obtained from the scale are 14 and 70 respectively. The higher the score obtained from the Functional and Emotional Dysmenorrhea Scale is, the higher the functional and emotional disturbance levels of the individual affected by dysmenorrhea are In the second stage of the study, of the students, those who obtained ≥42 points from the Functional and Emotional Dysmenorrhea Scale and those who obtained ≥5 points from the Visual Analogue Scale were included in the study.
Measured: It took approximately 5 minutes to fill out the form.
The Student Information Form
After the students who met the sample selection criteria and agreed to participate in the study were informed about the study, they were asked to fill in the Student Information Form.
Questions about the sociodemographic and menstruation characteristics of the students were asked using the Student Information Form developed by the researchers in line with the literature.
Measured: It took approximately 5 minutes to fill out the form.
Description of the students' comfort level.
On the first day of the participating students' menstruation, prior to the application (when the pain started), General Comfort Questionnaire (GCQ) were filled in at the pre-test. The lowest and highest possible scores that can be obtained from the General Comfort Questionnaire are 1 and 4 respectively. While 1 point indicates that the level of comfort is low, 4 points indicate that the level of comfort is high.
Measured: It was evaluated on the first day of the menstrual cycle before the application. It took approximately 5-10 minutes to fill out the form.
To evaluate assessing menstrual pain characteristics.
On the first day of the participating students' menstruation, prior to the application (when the pain started), Dysmenorrhea Follow-up Form were filled in at the pre-test. The questions in the form are as follows: time of onset of menstruation pain, the region where menstruation pain intensifies, the frequency of menstruation pain, the presence of complaints accompanying menstruation pain, the benefit of the method applied to relieve menstruation pain.
Measured: It was evaluated on the first day of the menstrual cycle before the application. It took approximately 1-2 minutes to fill out the form.
To evaluate the severity of pain secondary to dysmenorrhea with the Visual Analogue Scale (VAS)
We asked them to determine the severest pain score they felt on the first day of menstruation according to the Visual Analogue Scale (VAS).The highest pain score that can be obtained on the Visual Analogue Scale is 10 and the lowest is 0. The higher the score, the higher the pain intensity.
Measured: up to 2 days
To evaluate the effect of Hegu point ice massage in reducing the pain severity secondary to dysmenorrhea through a Visual Analogue Scale (VAS).
The Hegu point of the participating students was detected with the acupuncture point finder.
Ice cubes whose dimensions were 2x2x2 cm were wrapped with gauze and placed in a plastic bag. To prevent damage to the tissue and to ensure the sustainability of the movement, Vaseline® jelly was spread on the application area. We applied 2 minutes of ice massage 7 times at 15-second intervals. Melted ice cubes were replaced with new ones. As soon as the application was over, 30 and 60 minutes after the application, the participants' pain levels were assessed (Post-test). Pain intensity was measured with Visual Analogue Scale (VAS).The highest pain score that can be obtained on the Visual Analogue Scale is 10 and the lowest is 0. The higher the score, the higher the pain intensity. The procedure was performed once on the first day and once on the second day of menstruation.
Measured: up to 2 days
To evaluate the effect of music medicine in reducing the pain severity secondary to dysmenorrhea through a Visual Analogue Scale (VAS).
Depending on their preference, each participant wearing personalized headphones was played instrumental music in the first and second day of menstruation for 30 minutes. As soon as the application was over, 30 and 60 minutes after the application, the participants' pain levels were assessed (Post-test). Pain intensity was measured with Visual Analogue Scale (VAS).The highest pain score that can be obtained on the Visual Analogue Scale is 10 and the lowest is 0. The higher the score, the higher the pain intensity. The procedure was performed once on the first day and once on the second day of menstruation.
Measured: up to 2 days
To evaluate the effect of Hegu point ice massage in increasing comfort level.
On the second day of menstruation, the participants were asked to fill in the General Comfort Questionnaire (GCQ). The lowest and highest possible scores that can be obtained from the General Comfort Questionnaire are 1 and 4 respectively. While 1 point indicates that the level of comfort is low, 4 points indicate that the level of comfort is high.
Measured: It was evaluated on the second day of the menstrual cycle and after the application. It took approximately 5 minutes to fill out the form.
To evaluate the effect of music medicine in increasing comfort level.
On the second day of menstruation, the participants were asked to fill in the General Comfort Questionnaire (GCQ). The lowest and highest possible scores that can be obtained from the General Comfort Questionnaire are 1 and 4 respectively. While 1 point indicates that the level of comfort is low, 4 points indicate that the level of comfort is high.
Measured: It was evaluated on the second day of the menstrual cycle and after the application. It took approximately 5 minutes to fill out the form.
To determine the level of students being affected by dysmenorrhea.
On the second day of menstruation, the participants were asked to fill in the Effects of Dysmenorrhea Scale (EDS). It consists of 39 items and 11 sub-dimensions. Responses given to the items are rated on a 5-point Likert-type scale ranging from 1 to 5. The minimum and maximum possible scores to be obtained from the scale are 39 and 195 respectively. The higher the score obtained from the Effects of Dysmenorrhea Scale is, the higher the level of being affected by dysmenorrhea is.
Measured: It was evaluated on the second day of the menstrual cycle and after the application. It took approximately 5-10 minutes to fill out the form.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start20 Oct 2021
- Primary completion20 Dec 2021
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manisa Celal Bayar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevgi Çetin, Manisa Celal Bayar University
- Investigators
- Sevgi PAKİŞ ÇETİN, Res Asis Dr, Principal investigator, Manisa Celal Bayar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686460
- Sponsor's protocol ID
- CBU-PAKİSCETİN-1
- Status last verified
- Jan 2023
- First submitted
- 2 Jan 2023
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Hegu Point Ice Massage and Music on Pain and Comfort Levels in Dysmenorrhea
- ClinicalTrials.gov ID
- NCT05686460
- Acronym / sponsor ID
- CBU-PAKİSCETİN-1
- Conditions
- Primary Dysmenorrhea
- Keywords
- comfort, ice massage, music, pain, dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Manisa Celal Bayar UniversityUniversity, hospital or other
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 17 Jan 2023 (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.
Dysmenorrhea, a gynecological health problem that is frequently observed in adolescents and young adult women and often cannot be diagnosed is defined as pelvic pain associated with menstruation.
Providing analgesia without using pharmacological treatment is the leading aim of health care and can reduce drug-related complications. Therefore, nurses' awareness of the use of complementary and alternative medicine should be raised and the methods used should be based on evidence. Our search for studies in which the effects of listening to music and ice massage applied to the Hegu point on pain management in individuals with dysmenorrhea were investigated demonstrated that the number of such studies in the literature is not many. We think that the present study is important in terms of increasing the comfort levels of individuals with dysmenorrhea, basing the applications on evidence and contributing to the literature. It was conducted to compare the effects of ice massage applied to the Hegu point and music on pain and comfort levels in nursing students with dysmenorrhea.
Detailed description
Dysmenorrhea, a gynecological health problem that is frequently observed in adolescents and young adult women and often cannot be diagnosed, is defined as pelvic pain associated with menstruation. The prevalence of dysmenorrhea is reported to vary between 50% and 90% in women of reproductive age. Dysmenorrhea and the symptoms accompanying dysmenorrhea cause significant economic losses by leading to both work and school absenteeism. Particularly in adolescents, due to dysmenorrhea, participation in sports and social activities is restricted, indicators of academic performance such as school absenteeism, school success, concentration, productivity are negatively affected, and thus their levels of general comfort and quality of life decrease. On the other hand, pharmacological treatment options used in the treatment of dysmenorrhea are very few. On top of this, the effectiveness of these treatment options is still debated. Since the medication used in the pharmacological treatment of dysmenorrhea has various side effects, using non-pharmacological treatments in addition to pharmacological treatment in the management of dysmenorrhea would be beneficial.
Cold application is one of the effective, simple, inexpensive and reliable non-pharmacological methods used to reduce pain, with few complications or no side effects. The Hegu point, the most important pain relief point of the body, can be stimulated in all painful conditions. Another low-risk and low-cost nonpharmacological method for standard care used in pain management is the music medicine.
This randomized clinical trial was designed to determine the effects of ice massage applied to the Hegu point and music on dysmenorrhea, compared to a control group that no intervention in women of 18 years or older from the the Faculty of Health Sciences at the Manisa Celal Bayar University, Manisa, Turkey.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ice massage | Experimental | Behavioral: ice massageThe application applied 2 minutes of ice massage 7 times at 15-second intervals. The procedure was performed once on the first day and once on the second day of menstruation. |
| music medicine | Experimental | Behavioral: music medicineDepending on their preference, each participant wearing personalized headphones was played instrumental music in the pre-menstruation period for 30 minutes. The procedure was performed once on the first day and once on the second day of menstruation. |
| control | No intervention | –On the first and second days of menstruation, their pain levels of were assessed 4 times: when the pain started (pre-test), and then 30, 60 and 90 minutes after the pain started. |
Who may qualify
- Ages
- 18 to 33 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Having menstruation regularly (between 21 and 35 days),
- Not using traditional and complementary treatments such as analgesics or massage during the application,
- Not having a diagnosed psychiatric problem and a history of endometriosis in the past,
- Not having infection and ovarian cyst / tumor, not having a neuropathic problem that might cause diabetes or nerve damage,
- Being over 18 years of age and agreeing to participate in the study.
Key exclusion criteria (6 listed)
- Having hearing problems,
- Having connective tissue diseases,
- Having bleeding and coagulation disorders,
- Having fractures in the hand and arm to undergo therapy,
- Having sensitivity to cold,
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 |
|---|---|---|
| ice massageAfter the students who met the sample selection criteria applied Student Information Form. On the first day of the participating students' menstruation, prior to the application (when the pain started), the Visual Analogue Scale (VAS), General Comfort Questionnaire (GCQ) and Dysmenorrhea Follow-up Form were filled in at the pre-test. The Hegu point of the participating students was detected with the acupuncture point finder. Ice cubes whose dimensions were 2x2x2 cm were wrapped with gauze and placed in a plastic bag. Vaseline® jelly was spread on the application area. The application applied 2 minutes of ice massage 7 times at 15-second intervals. The participants' pain levels were assessed three times, as soon as the application was over, 30 and 60 minutes after the application (Post-test). On the second day of menstruation, the participants were asked to fill in the VAS, GCQ, and Effects of Dysmenorrhea Scale (EDS). | Behavioural | ice massage |
| music medicineAfter the students who met the sample selection criteria applied Student Information Form. On the first day of the participating students' menstruation, prior to the application (when the pain started), the Visual Analogue Scale (VAS), General Comfort Questionnaire (GCQ) and Dysmenorrhea Follow-up Form were filled in at the pre-test. Depending on their preference, each participant wearing personalized headphones was played instrumental music in the pre-menstruation period for 30 minutes. The volume of the music was adjusted based on the verbal feedback or facial expressions of the students. The participants' pain levels were assessed three times, as soon as the application was over, 30 and 60 minutes after the application (Post-test). On the second day of menstruation, the participants were asked to fill in the VAS, GCQ, and Effects of Dysmenorrhea Scale (EDS). | Behavioural | music medicine |
Primary outcome
Questions about the menstrual characteristics of the students were asked using the Dysmenorrhea identification form
Time frame: It took approximately 5-10 minutes to fill out the form.
Questions about the menstrual characteristics of the students were asked using the Dysmenorrhea identification form developed by the researchers in line with the literature.
The intensity of pain experienced during the last menstrual period was asked using the Visual Analogue Scale (VAS
Time frame: It took approximately 5-10 minutes to fill out the form.
The intensity of pain experienced during the last menstrual period was asked using the Visual Analogue Scale (VAS). The highest pain score that can be obtained on the Visual Analogue Scale is 10 and the lowest is 0. The higher the score, the higher the pain intensity.
To evaluate dysmenorrhea severity using Functional and Emotional Dysmenorrhea Scale.
Time frame: It took approximately 5 minutes to fill out the form.
We asked them to determine the emotions they experienced on the first day of menstruation in accordance with the Functional and Emotional Dysmenorrhea Scale developed by Li et al. The minimum and maximum possible scores to be obtained from the scale are 14 and 70 respectively. The higher the score obtained from the Functional and Emotional Dysmenorrhea Scale is, the higher the functional and emotional disturbance levels of the individual affected by dysmenorrhea are In the second stage of the study, of the students, those who obtained ≥42 points from the Functional and Emotional Dysmenorrhea Scale and those who obtained ≥5 points from the Visual Analogue Scale were included in the study.
The Student Information Form
Time frame: It took approximately 5 minutes to fill out the form.
After the students who met the sample selection criteria and agreed to participate in the study were informed about the study, they were asked to fill in the Student Information Form. Questions about the sociodemographic and menstruation characteristics of the students were asked using the Student Information Form developed by the researchers in line with the literature.
Description of the students' comfort level.
Time frame: It was evaluated on the first day of the menstrual cycle before the application. It took approximately 5-10 minutes to fill out the form.
On the first day of the participating students' menstruation, prior to the application (when the pain started), General Comfort Questionnaire (GCQ) were filled in at the pre-test. The lowest and highest possible scores that can be obtained from the General Comfort Questionnaire are 1 and 4 respectively. While 1 point indicates that the level of comfort is low, 4 points indicate that the level of comfort is high.
To evaluate assessing menstrual pain characteristics.
Time frame: It was evaluated on the first day of the menstrual cycle before the application. It took approximately 1-2 minutes to fill out the form.
On the first day of the participating students' menstruation, prior to the application (when the pain started), Dysmenorrhea Follow-up Form were filled in at the pre-test. The questions in the form are as follows: time of onset of menstruation pain, the region where menstruation pain intensifies, the frequency of menstruation pain, the presence of complaints accompanying menstruation pain, the benefit of the method applied to relieve menstruation pain.
To evaluate the severity of pain secondary to dysmenorrhea with the Visual Analogue Scale (VAS)
Time frame: up to 2 days
We asked them to determine the severest pain score they felt on the first day of menstruation according to the Visual Analogue Scale (VAS).The highest pain score that can be obtained on the Visual Analogue Scale is 10 and the lowest is 0. The higher the score, the higher the pain intensity.
To evaluate the effect of Hegu point ice massage in reducing the pain severity secondary to dysmenorrhea through a Visual Analogue Scale (VAS).
Time frame: up to 2 days
The Hegu point of the participating students was detected with the acupuncture point finder. Ice cubes whose dimensions were 2x2x2 cm were wrapped with gauze and placed in a plastic bag. To prevent damage to the tissue and to ensure the sustainability of the movement, Vaseline® jelly was spread on the application area. We applied 2 minutes of ice massage 7 times at 15-second intervals. Melted ice cubes were replaced with new ones. As soon as the application was over, 30 and 60 minutes after the application, the participants' pain levels were assessed (Post-test). Pain intensity was measured with Visual Analogue Scale (VAS).The highest pain score that can be obtained on the Visual Analogue Scale is 10 and the lowest is 0. The higher the score, the higher the pain intensity. The procedure was performed once on the first day and once on the second day of menstruation.
To evaluate the effect of music medicine in reducing the pain severity secondary to dysmenorrhea through a Visual Analogue Scale (VAS).
Time frame: up to 2 days
Depending on their preference, each participant wearing personalized headphones was played instrumental music in the first and second day of menstruation for 30 minutes. As soon as the application was over, 30 and 60 minutes after the application, the participants' pain levels were assessed (Post-test). Pain intensity was measured with Visual Analogue Scale (VAS).The highest pain score that can be obtained on the Visual Analogue Scale is 10 and the lowest is 0. The higher the score, the higher the pain intensity. The procedure was performed once on the first day and once on the second day of menstruation.
To evaluate the effect of Hegu point ice massage in increasing comfort level.
Time frame: It was evaluated on the second day of the menstrual cycle and after the application. It took approximately 5 minutes to fill out the form.
On the second day of menstruation, the participants were asked to fill in the General Comfort Questionnaire (GCQ). The lowest and highest possible scores that can be obtained from the General Comfort Questionnaire are 1 and 4 respectively. While 1 point indicates that the level of comfort is low, 4 points indicate that the level of comfort is high.
To evaluate the effect of music medicine in increasing comfort level.
Time frame: It was evaluated on the second day of the menstrual cycle and after the application. It took approximately 5 minutes to fill out the form.
On the second day of menstruation, the participants were asked to fill in the General Comfort Questionnaire (GCQ). The lowest and highest possible scores that can be obtained from the General Comfort Questionnaire are 1 and 4 respectively. While 1 point indicates that the level of comfort is low, 4 points indicate that the level of comfort is high.
To determine the level of students being affected by dysmenorrhea.
Time frame: It was evaluated on the second day of the menstrual cycle and after the application. It took approximately 5-10 minutes to fill out the form.
On the second day of menstruation, the participants were asked to fill in the Effects of Dysmenorrhea Scale (EDS). It consists of 39 items and 11 sub-dimensions. Responses given to the items are rated on a 5-point Likert-type scale ranging from 1 to 5. The minimum and maximum possible scores to be obtained from the scale are 39 and 195 respectively. The higher the score obtained from the Effects of Dysmenorrhea Scale is, the higher the level of being affected by dysmenorrhea is.
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 17 Jan 2023.
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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.
Sevgi PAKİŞ ÇETİN, Res Asis Dr principal investigator
Manisa Celal Bayar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ice massage and music medicine in people with Primary Dysmenorrhea, run by Manisa Celal Bayar 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 5 inclusion and 6 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 17 Jan 2023. 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?
Questions about the menstrual characteristics of the students were asked using the Dysmenorrhea identification form (time frame: It took approximately 5-10 minutes to fill out the form.). The study lists 12 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 17 Jan 2023; AzTrials last refreshed its copy on 8 Nov 2026.