Ignite Creation Date:
2024-05-06 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06027489
Status:
COMPLETED
Last Update Posted:
2023-12-13
First Post:
2023-08-30
Brief Title:
Listening Music Drawing on Coping With Dysmenorrhea Complaints of Nursing Students
Sponsor:
Trakya University
Organization:
Trakya University
Study Overview
Official Title:
The Effect of Listening to Music and Drawing on the Coping With Dysmenorrhea of Nursing Students Experiencing Dysmenorrhea
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 The current study addresses this research question
Design A three-arm randomized controlled trial was conducted in 96 nursing students with dysmenorrhea
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 111 ratio according to a computer-generated randomization scheme via httpswwwsealedenvelopecomsimple-randomiserv1
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 httpssoundcloudcomjss-martinoccasio-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 mothers education level mothers employment status fathers education level fathers 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 0no pain and 10worst 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 effectssomatic 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 Cronbachs Alpha value is 086 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 GPOWER 3197 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 075 margin of error of α005 and minimum power80 β02 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
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 111 ratio according to a computer-generated randomization scheme via httpswwwsealedenvelopecomsimple-randomiserv1
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 httpssoundcloudcomjss-martinoccasio-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 mothers education level mothers employment status fathers education level fathers 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 0no pain and 10worst 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 effectssomatic 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 Cronbachs Alpha value is 086 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 GPOWER 3197 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 075 margin of error of α005 and minimum power80 β02 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None