Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06027489 |
| Other study ID # |
2023/SBB/0415 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 20, 2023 |
| Est. completion date |
December 9, 2023 |
Study information
| Verified date |
December 2023 |
| Source |
Trakya University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. The current study addresses this research question..
Design: A three-arm randomized controlled trial was conducted in 96 nursing students with
dysmenorrhea.
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.
