MusicNCT06027489
Listening Music, Drawing on Coping With Dysmenorrhea Complaints of Nursing Students
A study testing Music and Drawing Group in people with Music and Drawing, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
Objectives: Investigating the effects of listening to music and drawing on nursing students with dysmenorrhea on dysmenorrhea complaints is a new and promising area of research. However, high-level evidence on whether listening to music and drawing has an effect on dysmenorrhea complaints is insufficient. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Music, Drawing, Coping Behavior
- What is being tested?
- Music and Drawing Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2023to 9 Dec 2023
- 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 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Has not given birth,
- The ages of 18-25,
- Having a regular menstrual cycle (28±7 days),
- Menstrual pain severity in the previous month is 5 or higher on the Visual Analogue Scale (VAS),
- Having dysmenorrhea,
- Having their written consent,
- Nursing students who volunteered to participate in the study
Who cannot join
- Hearing loss
- Having chronic disease such as pelvic pathology, neurological, endocrine or psychiatric disease and diabetes mellitus or heart disease,
- Currently using drugs such as antidepressants or oral contraceptives,
- Havingmenstrual irregularity,
- Having mental problems that prevent evaluation and cooperation,
- Obesity, malignant condition, pelvic surgery, pregnancy,
Show all 9Show fewer
- Using analgesics,
- Using medication or non-drug practices (reiki, meditation, reflexology, acupressure, etc.),
- Nursing students who did not volunteer to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Listening to Music and Drawing on the Coping With Dysmenorrhea of Nursing Students Experiencing Dysmenorrhea
Objectives: Investigating the effects of listening to music and drawing on nursing students with dysmenorrhea on dysmenorrhea complaints is a new and promising area of research. However, high-level evidence on whether listening to music and drawing has an effect on dysmenorrhea complaints is insufficient. The current study addresses this research question..
Design: A three-arm randomized controlled trial was conducted in 96 nursing students with dysmenorrhea.
Read the detailed description
This three-armed randomized controlled study (RCT) will be conducted in July 2023 in Bartın University Faculty of Health Sciences Nursing Department students experiencing dysmenorrhea. Nursing students who experienced dysmenorrhea at the time of application were informed about the aims, setup and intervention of the study. and evaluated for suitability in a short, standardized interview. Nursing students experiencing dysmenorrhea who met our criteria were given a basic questionnaire along with a letter of information and an informed consent form. Nursing students with dysmenorrhea gave written informed consent for participation in the study were included. Evaluations in all three groups were made before randomization (ie baseline) and immediately after the intervention periods (2nd and 3rd month).
Randomization: The randomization list was made by another scientist who was not involved in the research process in order to preserve the random selection order and to prevent bias, and with this blinding applied, the group allocation was hidden. A computer randomization program was used to generate the randomization list for the intervention allocation sequence. Individuals who received a voluntary consent form and volunteered to participate in the research were randomly assigned to the experimental and control groups by using the blocking method. Following simple randomization procedures, participants were assigned to one of the three arms of the study in a 1:1:1 ratio according to a computer-generated randomization scheme via https://www.sealedenvelope.com/simple-randomiser/v1.
In this research, the allocation of participants to groups was made by scientists who were not involved in the research. Due to the nature of the research, the follow-up of the practices and the participants will not be provided during the data collection process, as the researcher does it.
Intervention:
Music Group: In the second and third months, participants listened to a song that lasted 29 minutes and 32 seconds for four days (three days before menstruation and the first day of menstruation). The song to be played was determined by examining the literature, the song was composed by researcher Juan Sebastian Martin-Saavedra and was named Occasio Adolore (Music Piece No. 5-559-355 and Phonogram No. 12-105-295) by the author copyright institution of Colombia. registered under. While the researcher is composing the song, it is to create a piece of music that will reduce the pain felt, activate positive emotions and relax the person. The composed song is available online within the scope of the published article (https://soundcloud.com/jss-martin/occasio-adolore). Written permission was obtained from Juan Sebastian Martin-Saavedra to use the composed song in the research. The access link of the composed song will be sent to the participants via social media (WhatsApp). After listening to music for three days before the menstrual cycle and on the first day of menstruation (for a total of four days), pain, menstrual symptoms and perceived stress on the first day of menstruation will be measured using VAS, MSS, and PSS, respectively.
Drawing Group: In the second and third months, the participants will be asked to paint for 29 minutes and 32 seconds (the duration of the intervention was determined in parallel with the music group in order not to create variability between the groups) for four days (three days before menstruation and the first day of menstruation). The type of paint to be used in the drawn picture (dry pen, crayon or watercolor) is left to the availability of the participants, and it will be stated that they prefer colors and drawings that will raise their emotions, focus their drawings and feed positive emotions in the picture to be drawn. After drawing pictures three days before the menstrual cycle and the first day of menstruation (for a total of four days), pain, menstrual symptoms, and perceived stress on the first day of menstruation will be measured using the VAS, MSS, and PSS, respectively.
Control Group: Nursing students with dysmenorrhea in the control group were informed that drawing and listening to music practices would be performed after the initial, second and third month evaluations of the study. In the meantime, it was stated that he should not make any interventions other than her routine applications. At baseline, second, and third month, participants will measure pain, menstrual symptoms, and perceived stress on the first day of the menstrual cycle using the VAS, MSS, and PSS, respectively.
Measures: "Personal Information Form", "Visual Analog Scale (VAS)", "Menstruation Symptom Scale (MSS)" and "Perceived Stress Scale (PSS)" were used in the study.
Personal Information Form: It consists of a total of 36 questions, including socio-demographic characteristics and features related to the menstrual cycle. Within the scope of socio-demographic characteristics; age, height, weight, bki, mother's education level, mother's employment status, father's education level, father's employment status, income status, family type, smoking status, alcohol use status, physical exercise status, place of residence during education life, heavy There are questions such as dominant personality structure, perspective on life. Within the scope of the characteristics related to the menstrual cycle, the first menarche age, the duration of the menstrual cycle, its frequency, the regularity of the menstrual cycle, the reaction of waiting to be menstrual before the menstrual cycle, the feeling of cramp-like pain (dysmenorrhea) in the lower part of the abdomen in the first days of the menstrual cycle, the state of feeling experienced during the menstrual cycle. Problems and coping methods, duration of dysmenorrhea complaint, use of pharmacological treatment method in dysmenorrhea, use of traditional and alternative treatment methods in dysmenorrhea, information source and sharing with a health professional if using, status and frequency of applying to the emergency department with dysmenorrhea complaints are included. The questions were prepared by the researchers in line with the literature, and expert opinion was taken after the questionnaire was prepared.
Visual Analog Scale (VAS): The intensity of menstrual pain will be measured using the VAS, a valid and reliable tool to measure experimental and clinical pain. The VAS is scored on a horizontal line of 10 cm (0=no pain and 10=worst possible pain).
The Menstruation Symptom Scale (MSS): This scale was developed in English by Chesney and Tasto in 1975 to assess menstrual pain and symptoms. It is a widely used scale in the United States and many different countries. The factor structure and usability on adolescents were reassessed and updated. The adaptation of the scale to Turkish was done. Participants are asked to give a number between 1 (never) and 5 (always) for the symptoms they experience about menstruation. The items of the scale are numbered according to the factors set aside for ease of use. 1-13. The items belong to the "Negative effects/somatic complaints" sub-dimension, 14-19. Items included in the "Menstrual pain symptoms" sub-dimension and 20-22. items belong to the sub-dimension "Coping methods". Cronbach's Alpha value is 0.86. It is a five-point Likert-type scale consisting of 22 items. The score obtained from the sub-dimensions is calculated by taking the total score average of the items in the sub-dimensions. The increase in the mean score for the sub-dimensions indicates that the severity of menstrual symptoms related to that sub-dimension increases.
Perceived Stress Scale (PSS): This scale is a self-rating scale developed. The total score that can be obtained from the scale is 32. A high total score from the scale, which consists of 10 items and scored between 0-4, indicates a high level of stress. In this study, the scale whose Turkish validity and reliability study was conducted was used.
Sample size calculation for the primary research question was performed based on a pilot study. Power analysis of this research was done with G*POWER 3.1.9.7 (Power analysis statistical software). In determining the sample size, the value of menstrual pain intensity was taken as the basis. It was determined that 28 individuals from each group would be sufficient to participate in the study, with an effect size of 0.75, margin of error of α=0.05 and minimum power=80% (β=0.2). However, considering the possible missing data, it was decided to include 32 female nursing students in the study by making 10% increase in each group.
- Conditions
- Music, Drawing, Coping Behavior, Dysmenorrhea, Symptom, Depressive, Dysmenorrhea Symptom
- Being tested
- Music, Drawing Group
- Keywords
- Music, Drawing, Nursing Students, Dysmenorrhea
- Medical subject headings
- Dysmenorrhea, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicBehavioural
In the second and third months, participants listened to a song that lasted 29 minutes and 32 seconds for four days (three days before menstruation and the first day of menstruation). The song to be played was determined by examining the literature, the song was composed by researcher Juan Sebastian Martin-Saavedra and was named Occasio Adolore (Music Piece No. 5-559-355 and Phonogram No. 12-105-295) by the author copyright institution of Colombia. registered under. While the researcher is composing the song, it is to create a piece of music that will reduce the pain felt, activate positive emotions and relax the person. The composed song is available online within the scope of the published article (https://soundcloud.com/jss-martin/occasio-adolore).
Drawing GroupBehavioural
: In the second and third months, the participants will be asked to paint for 29 minutes and 32 seconds (the duration of the intervention was determined in parallel with the music group in order not to create variability between the groups) for four days (three days before menstruation and the first day of menstruation). The type of paint to be used in the drawn picture (dry pen, crayon or watercolor) is left to the availability of the participants, and it will be stated that they prefer colors and drawings that will raise their emotions, focus their drawings and feed positive emotions in the picture to be drawn.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Nursing students with dysmenorrhea in the control group were informed that drawing and listening to music practices would be performed after the initial, second and third month evaluations of the study. In the meantime, it was stated that he should not make any interventions other than her routine applications. At baseline, second, and third month, participants will measure pain, menstrual symptoms, and perceived stress on the first day of the menstrual cycle using the VAS, MSS, and PSS, respectively. |
| Music Group | Experimental | In the second and third months, participants listened to a song that lasted 29 minutes and 32 seconds for four days (three days before menstruation and the first day of menstruation). The song to be played was determined by examining the literature, the song was composed by researcher Juan Sebastian Martin-Saavedra and was named Occasio Adolore (Music Piece No. 5-559-355 and Phonogram No. 12-105-295) by the author copyright institution of Colombia. registered under. While the researcher is composing the song, it is to create a piece of music that will reduce the pain felt, activate positive emotions and relax the person. The composed song is available online within the scope of the published article (https://soundcloud.com/jss-martin/occasio-adolore) [21]. Written permission was obtained from Juan Sebastian Martin-Saavedra to use the composed song in the research. The access link of the composed song will be sent to the participants via social media (WhatsApp). Receives: Behavioral: Music |
| Drawing Group | Experimental | In the second and third months, the participants will be asked to paint for 29 minutes and 32 seconds (the duration of the intervention was determined in parallel with the music group in order not to create variability between the groups) for four days (three days before menstruation and the first day of menstruation). The type of paint to be used in the drawn picture (dry pen, crayon or watercolor) is left to the availability of the participants, and it will be stated that they prefer colors and drawings that will raise their emotions, focus their drawings and feed positive emotions in the picture to be drawn. After drawing pictures three days before the menstrual cycle and the first day of menstruation (for a total of four days), pain, menstrual symptoms, and perceived stress on the first day of menstruation will be measured using the VAS, MSS, and PSS, respectively. Receives: Behavioral: Drawing Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain evaluated using the Visual Analog Scale.
The intensity of pain is measured using the VAS, a valid and reliable tool for measuring experimental and clinical pain. The VAS is scored on a horizontal line of 10 cm (0=no pain and 10=worst possible pain).
Measured: change from before implamentation patent and after 2. and 3. month of practice.
Mensruation symptom evaluated using the Menstruation Symptom Scale (MSS).
This scale was developed in English by Chesney and Tasto in 1975 to assess menstrual pain and symptoms. It is a widely used scale in the United States and many different countries. In 2009, Negriff et al. The factor structure and usability on adolescents were reassessed and updated. The adaptation of the scale to Turkish was done by Güvenç et al. in 2014. Participants are asked to give a number between 1 (never) and 5 (always) for the symptoms they experience about menstruation. Cronbach's Alpha value is 0.86. It is a five-point Likert-type scale consisting of 22 items. The score obtained from the sub-dimensions is calculated by taking the total score average of the items in the sub-dimensions. The increase in the mean score for the sub-dimensions indicates that the severity of menstrual symptoms related to that sub-dimension increases.
Measured: change from before implamentation patent and after 2. and 3. month of practice.
Perceive stress evaluated using the Perceived Stress Scale (PSS).
This scale is a self-rating scale developed by Cohen, Kamarck, and Mermelstein (1983). The total score that can be obtained from the scale is 32. A high total score from the scale, which consists of 10 items and scored between 0-4, indicates a high level of stress. In this study, the scale whose Turkish validity and reliability study was conducted by Bilge, Öğce, Genç, and Oran (2009) was used.
Measured: change from before implamentation patent and after 2. and 3. month of practice.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start20 Jul 2023
- Primary completion20 Sep 2023
- Study completion9 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MusicStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu KUCUKKAYA, Bartın Unıversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027489
- Sponsor's protocol ID
- 2023/SBB/0415
- Status last verified
- Dec 2023
- First submitted
- 30 Aug 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kucukkaya B, Basgol S. The effect of listening to music and drawing on coping with dysmenorrhea complaints in nursing students: randomized controlled trial. BMC Womens Health. 2024 Oct 25;24(1):571. doi: 10.1186/s12905-024-03398-0.
PubMed 39455971
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Listening to Music and Drawing on the Coping With Dysmenorrhea of Nursing Students Experiencing Dysmenorrhea
- ClinicalTrials.gov ID
- NCT06027489
- Acronym / sponsor ID
- 2023/SBB/0415
- Conditions
- Music, Drawing, Coping Behavior, Dysmenorrhea, Symptom, Depressive, Dysmenorrhea Symptom
- Keywords
- Music, Drawing, Nursing Students, Dysmenorrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 9 Dec 2023 (actual)
- First posted
- 7 Sep 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.
Objectives: Investigating the effects of listening to music and drawing on nursing students with dysmenorrhea on dysmenorrhea complaints is a new and promising area of research. However, high-level evidence on whether listening to music and drawing has an effect on dysmenorrhea complaints is insufficient. The current study addresses this research question..
Design: A three-arm randomized controlled trial was conducted in 96 nursing students with dysmenorrhea.
Detailed description
This three-armed randomized controlled study (RCT) will be conducted in July 2023 in Bartın University Faculty of Health Sciences Nursing Department students experiencing dysmenorrhea. Nursing students who experienced dysmenorrhea at the time of application were informed about the aims, setup and intervention of the study. and evaluated for suitability in a short, standardized interview. Nursing students experiencing dysmenorrhea who met our criteria were given a basic questionnaire along with a letter of information and an informed consent form. Nursing students with dysmenorrhea gave written informed consent for participation in the study were included. Evaluations in all three groups were made before randomization (ie baseline) and immediately after the intervention periods (2nd and 3rd month).
Randomization: The randomization list was made by another scientist who was not involved in the research process in order to preserve the random selection order and to prevent bias, and with this blinding applied, the group allocation was hidden. A computer randomization program was used to generate the randomization list for the intervention allocation sequence. Individuals who received a voluntary consent form and volunteered to participate in the research were randomly assigned to the experimental and control groups by using the blocking method. Following simple randomization procedures, participants were assigned to one of the three arms of the study in a 1:1:1 ratio according to a computer-generated randomization scheme via https://www.sealedenvelope.com/simple-randomiser/v1.
In this research, the allocation of participants to groups was made by scientists who were not involved in the research. Due to the nature of the research, the follow-up of the practices and the participants will not be provided during the data collection process, as the researcher does it.
Intervention:
Music Group: In the second and third months, participants listened to a song that lasted 29 minutes and 32 seconds for four days (three days before menstruation and the first day of menstruation). The song to be played was determined by examining the literature, the song was composed by researcher Juan Sebastian Martin-Saavedra and was named Occasio Adolore (Music Piece No. 5-559-355 and Phonogram No. 12-105-295) by the author copyright institution of Colombia. registered under. While the researcher is composing the song, it is to create a piece of music that will reduce the pain felt, activate positive emotions and relax the person. The composed song is available online within the scope of the published article (https://soundcloud.com/jss-martin/occasio-adolore). Written permission was obtained from Juan Sebastian Martin-Saavedra to use the composed song in the research. The access link of the composed song will be sent to the participants via social media (WhatsApp). After listening to music for three days before the menstrual cycle and on the first day of menstruation (for a total of four days), pain, menstrual symptoms and perceived stress on the first day of menstruation will be measured using VAS, MSS, and PSS, respectively.
Drawing Group: In the second and third months, the participants will be asked to paint for 29 minutes and 32 seconds (the duration of the intervention was determined in parallel with the music group in order not to create variability between the groups) for four days (three days before menstruation and the first day of menstruation). The type of paint to be used in the drawn picture (dry pen, crayon or watercolor) is left to the availability of the participants, and it will be stated that they prefer colors and drawings that will raise their emotions, focus their drawings and feed positive emotions in the picture to be drawn. After drawing pictures three days before the menstrual cycle and the first day of menstruation (for a total of four days), pain, menstrual symptoms, and perceived stress on the first day of menstruation will be measured using the VAS, MSS, and PSS, respectively.
Control Group: Nursing students with dysmenorrhea in the control group were informed that drawing and listening to music practices would be performed after the initial, second and third month evaluations of the study. In the meantime, it was stated that he should not make any interventions other than her routine applications. At baseline, second, and third month, participants will measure pain, menstrual symptoms, and perceived stress on the first day of the menstrual cycle using the VAS, MSS, and PSS, respectively.
Measures: "Personal Information Form", "Visual Analog Scale (VAS)", "Menstruation Symptom Scale (MSS)" and "Perceived Stress Scale (PSS)" were used in the study.
Personal Information Form: It consists of a total of 36 questions, including socio-demographic characteristics and features related to the menstrual cycle. Within the scope of socio-demographic characteristics; age, height, weight, bki, mother's education level, mother's employment status, father's education level, father's employment status, income status, family type, smoking status, alcohol use status, physical exercise status, place of residence during education life, heavy There are questions such as dominant personality structure, perspective on life. Within the scope of the characteristics related to the menstrual cycle, the first menarche age, the duration of the menstrual cycle, its frequency, the regularity of the menstrual cycle, the reaction of waiting to be menstrual before the menstrual cycle, the feeling of cramp-like pain (dysmenorrhea) in the lower part of the abdomen in the first days of the menstrual cycle, the state of feeling experienced during the menstrual cycle. Problems and coping methods, duration of dysmenorrhea complaint, use of pharmacological treatment method in dysmenorrhea, use of traditional and alternative treatment methods in dysmenorrhea, information source and sharing with a health professional if using, status and frequency of applying to the emergency department with dysmenorrhea complaints are included. The questions were prepared by the researchers in line with the literature, and expert opinion was taken after the questionnaire was prepared.
Visual Analog Scale (VAS): The intensity of menstrual pain will be measured using the VAS, a valid and reliable tool to measure experimental and clinical pain. The VAS is scored on a horizontal line of 10 cm (0=no pain and 10=worst possible pain).
The Menstruation Symptom Scale (MSS): This scale was developed in English by Chesney and Tasto in 1975 to assess menstrual pain and symptoms. It is a widely used scale in the United States and many different countries. The factor structure and usability on adolescents were reassessed and updated. The adaptation of the scale to Turkish was done. Participants are asked to give a number between 1 (never) and 5 (always) for the symptoms they experience about menstruation. The items of the scale are numbered according to the factors set aside for ease of use. 1-13. The items belong to the "Negative effects/somatic complaints" sub-dimension, 14-19. Items included in the "Menstrual pain symptoms" sub-dimension and 20-22. items belong to the sub-dimension "Coping methods". Cronbach's Alpha value is 0.86. It is a five-point Likert-type scale consisting of 22 items. The score obtained from the sub-dimensions is calculated by taking the total score average of the items in the sub-dimensions. The increase in the mean score for the sub-dimensions indicates that the severity of menstrual symptoms related to that sub-dimension increases.
Perceived Stress Scale (PSS): This scale is a self-rating scale developed. The total score that can be obtained from the scale is 32. A high total score from the scale, which consists of 10 items and scored between 0-4, indicates a high level of stress. In this study, the scale whose Turkish validity and reliability study was conducted was used.
Sample size calculation for the primary research question was performed based on a pilot study. Power analysis of this research was done with G*POWER 3.1.9.7 (Power analysis statistical software). In determining the sample size, the value of menstrual pain intensity was taken as the basis. It was determined that 28 individuals from each group would be sufficient to participate in the study, with an effect size of 0.75, margin of error of α=0.05 and minimum power=80% (β=0.2). However, considering the possible missing data, it was decided to include 32 female nursing students in the study by making 10% increase in each group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Nursing students with dysmenorrhea in the control group were informed that drawing and listening to music practices would be performed after the initial, second and third month evaluations of the study. In the meantime, it was stated that he should not make any interventions other than her routine applications. At baseline, second, and third month, participants will measure pain, menstrual symptoms, and perceived stress on the first day of the menstrual cycle using the VAS, MSS, and PSS, respectively. |
| Music Group | Experimental | Behavioral: MusicIn the second and third months, participants listened to a song that lasted 29 minutes and 32 seconds for four days (three days before menstruation and the first day of menstruation). The song to be played was determined by examining the literature, the song was composed by researcher Juan Sebastian Martin-Saavedra and was named Occasio Adolore (Music Piece No. 5-559-355 and Phonogram No. 12-105-295) by the author copyright institution of Colombia. registered under. While the researcher is composing the song, it is to create a piece of music that will reduce the pain felt, activate positive emotions and relax the person. The composed song is available online within the scope of the published article (https://soundcloud.com/jss-martin/occasio-adolore) [21]. Written permission was obtained from Juan Sebastian Martin-Saavedra to use the composed song in the research. The access link of the composed song will be sent to the participants via social media (WhatsApp). |
| Drawing Group | Experimental | Behavioral: Drawing GroupIn the second and third months, the participants will be asked to paint for 29 minutes and 32 seconds (the duration of the intervention was determined in parallel with the music group in order not to create variability between the groups) for four days (three days before menstruation and the first day of menstruation). The type of paint to be used in the drawn picture (dry pen, crayon or watercolor) is left to the availability of the participants, and it will be stated that they prefer colors and drawings that will raise their emotions, focus their drawings and feed positive emotions in the picture to be drawn. After drawing pictures three days before the menstrual cycle and the first day of menstruation (for a total of four days), pain, menstrual symptoms, and perceived stress on the first day of menstruation will be measured using the VAS, MSS, and PSS, respectively. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Has not given birth,
- The ages of 18-25,
- Having a regular menstrual cycle (28±7 days),
- Menstrual pain severity in the previous month is 5 or higher on the Visual Analogue Scale (VAS),
- Having dysmenorrhea,
Key exclusion criteria (9 listed)
- Hearing loss
- Having chronic disease such as pelvic pathology, neurological, endocrine or psychiatric disease and diabetes mellitus or heart disease,
- Currently using drugs such as antidepressants or oral contraceptives,
- Havingmenstrual irregularity,
- Having mental problems that prevent evaluation and cooperation,
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 |
|---|---|---|
| MusicIn the second and third months, participants listened to a song that lasted 29 minutes and 32 seconds for four days (three days before menstruation and the first day of menstruation). The song to be played was determined by examining the literature, the song was composed by researcher Juan Sebastian Martin-Saavedra and was named Occasio Adolore (Music Piece No. 5-559-355 and Phonogram No. 12-105-295) by the author copyright institution of Colombia. registered under. While the researcher is composing the song, it is to create a piece of music that will reduce the pain felt, activate positive emotions and relax the person. The composed song is available online within the scope of the published article (https://soundcloud.com/jss-martin/occasio-adolore). | Behavioural | Music Group |
| Drawing Group: In the second and third months, the participants will be asked to paint for 29 minutes and 32 seconds (the duration of the intervention was determined in parallel with the music group in order not to create variability between the groups) for four days (three days before menstruation and the first day of menstruation). The type of paint to be used in the drawn picture (dry pen, crayon or watercolor) is left to the availability of the participants, and it will be stated that they prefer colors and drawings that will raise their emotions, focus their drawings and feed positive emotions in the picture to be drawn. | Behavioural | Drawing Group |
Primary outcome
Pain evaluated using the Visual Analog Scale.
Time frame: change from before implamentation patent and after 2. and 3. month of practice.
The intensity of pain is measured using the VAS, a valid and reliable tool for measuring experimental and clinical pain. The VAS is scored on a horizontal line of 10 cm (0=no pain and 10=worst possible pain).
Mensruation symptom evaluated using the Menstruation Symptom Scale (MSS).
Time frame: change from before implamentation patent and after 2. and 3. month of practice.
This scale was developed in English by Chesney and Tasto in 1975 to assess menstrual pain and symptoms. It is a widely used scale in the United States and many different countries. In 2009, Negriff et al. The factor structure and usability on adolescents were reassessed and updated. The adaptation of the scale to Turkish was done by Güvenç et al. in 2014. Participants are asked to give a number between 1 (never) and 5 (always) for the symptoms they experience about menstruation. Cronbach's Alpha value is 0.86. It is a five-point Likert-type scale consisting of 22 items. The score obtained from the sub-dimensions is calculated by taking the total score average of the items in the sub-dimensions. The increase in the mean score for the sub-dimensions indicates that the severity of menstrual symptoms related to that sub-dimension increases.
Perceive stress evaluated using the Perceived Stress Scale (PSS).
Time frame: change from before implamentation patent and after 2. and 3. month of practice.
This scale is a self-rating scale developed by Cohen, Kamarck, and Mermelstein (1983). The total score that can be obtained from the scale is 32. A high total score from the scale, which consists of 10 items and scored between 0-4, indicates a high level of stress. In this study, the scale whose Turkish validity and reliability study was conducted by Bilge, Öğce, Genç, and Oran (2009) was used.
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 13 Dec 2023.
- Derived from this study: PubMed 39455971Kucukkaya B, Basgol S. The effect of listening to music and drawing on coping with dysmenorrhea complaints in nursing students: randomized controlled trial. BMC Womens Health. 2024 Oct 25;24(1):571. doi: 10.1186/s12905-024-03398-0.
- Individual participant dataSharing planned: Undecided
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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 Music and Drawing Group in people with Music and Drawing, run by Trakya 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 7 inclusion and 9 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 13 Dec 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?
Pain evaluated using the Visual Analog Scale. (time frame: change from before implamentation patent and after 2. and 3. month of practice.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06027489, which also lists 1 linked publication.
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 13 Dec 2023.