NCT06027489

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 30, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 7, 2023

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2023

Completed
Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

2 months

First QC Date

August 30, 2023

Last Update Submit

December 12, 2023

Conditions

Keywords

MusicDrawingNursing StudentsDysmenorrhea

Outcome Measures

Primary Outcomes (3)

  • 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).

    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.

    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.

    change from before implamentation patent and after 2. and 3. month of practice.

Study Arms (3)

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).

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.

Behavioral: Drawing Group

Interventions

MusicBEHAVIORAL

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).

Music Group
Drawing GroupBEHAVIORAL

: 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.

Drawing Group

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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,
  • Using analgesics,
  • Using medication or non-drug practices (reiki, meditation, reflexology, acupressure, etc.),
  • Nursing students who did not volunteer to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bartın University

Bartın, 74010, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DysmenorrheaDepression

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainPainNeurologic ManifestationsSigns and SymptomsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof

Study Record Dates

First Submitted

August 30, 2023

First Posted

September 7, 2023

Study Start

July 20, 2023

Primary Completion

September 20, 2023

Study Completion

December 9, 2023

Last Updated

December 13, 2023

Record last verified: 2023-12

Locations