NCT04356131

Brief Summary

A total of 97 female students, 50 in the intervention group and 47 in the control group, were included in this pretest-posttest design randomized controlled study. Massage and progressive relaxation exercises are self-administered practices that are easy to adopt, with no side effects, and have beneficial effects on pain, sweating, fatigue, and gastrointestinal and central nervous system signs. So, it can be asserted that when applied together, massage and progressive relaxation exercises could be more effective in reducing menstrual symptoms than applying them separately.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

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

May 1, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 22, 2020

Completed
Last Updated

May 12, 2021

Status Verified

May 1, 2021

Enrollment Period

8 months

First QC Date

April 16, 2020

Last Update Submit

May 8, 2021

Conditions

Keywords

DysmenorrhoeaMassageProgressive relaxation exercisesPainMenstrual symptomRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Students' individual and menstruation-related characteristics as assessed by "The Personal Information Form".

    At the pretest stage of the research, by the experimental group and control group, "The Personal Information Form" form is filled in to specify individual characteristics and menstruation period characteristics.

    1 day

Secondary Outcomes (2)

  • Students' Menstruation Period Pain as assessed by The short-form McGill Pain Questionnaire.

    28 day

  • Students' Menstruation Period Menstrual Symptoms as assessed by Daily Symptom Rating Scale.

    28 day

Study Arms (2)

experimental group

EXPERIMENTAL

Students in the experimental group were taught about massage and progressive relaxation exercises (PRE). The phases of the massage and PRE trainings were first explained by being demonstrated by the author on herself. In the meantime, the trainings were video-taped and uploaded to the mobile phones of the students. After the author, each student was made to perform massage and PRE. Both the exercises and massage techniques were daily performed 3 times a day after pain had started and relaxation exercises lasted 30 minutes whereas massage was performed for 15 minutes consecutively

Other: progressive relaxation exercises and massage

control group

NO INTERVENTION

The students in the control group continued their routines during the study.

Interventions

Progressive relaxation exercises included 30 minute rhythmic breathing and muscle relaxation exercises were demonstrated in the second part of the CD with river sounds and verbal instructions. Massage techniques were performed on the site between upper symphysis pubis and umbilicus with 15 minute effleurage demonstrated in the third part of the CD with nature sound.

experimental group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPrimary dysmenorrhoea is described as painful menstrual periods among women who have normal pelvic anatomy and causes physical and psychological health to be affected with hormonal changes as well as some symptoms such as nausea, vomiting, fatigue and stress.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being older than 18 years,
  • Having a dysmenorrhea pain intensity score ≥4 according to Visual Analog Scale (VAS),
  • Having no previous pregnancy experience,
  • Having no disease that leads to dysmenorrhea,
  • Using no hormonal contraception or intrauterine device,
  • Having a menstruation period of 3-8 days and a menstrual cycle of 21-35 days,
  • Having no systemic-chronic disease or physical/mental health problems that prevent/restrict massage or exercise,
  • Volunteering to participate in the study.

You may not qualify if:

  • Being younger than 18 years
  • Having a dysmenorrhea pain intensity score ≤ 4 according to Visual Analog Scale (VAS),
  • Having previous pregnancy experience,
  • Having disease that leads to dysmenorrhoea (endometriosis, ovarian cysts/tumors, pelvic infection disease, myoma/uterus tumor, uterus polyp, asherman syndrome, infection),
  • Using hormonal contraception and intrauterine devices,
  • Not to present a menstruation period that lasts 3-8 days and menstrual cycle of 21-35 days,
  • Having a systemic and chronic disease (diabetes, heart diseases, vein diseases, circulatory disorders, varicosis, blood diseases, etc.),
  • Having any physical/mental health problems that prevent/restrict massaging and exercising,
  • Not to be voluntary to join the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mersin University Faculty of Nursing

Mersin, Turkey (Türkiye)

Location

Related Publications (7)

  • Avcı D.K, Sarı E. Approach to dysmenorrhea and effect of dysmenorrhea on social life and school performance in the university students. Van Medical Journal. 2018; 25(2): 188-193.

    BACKGROUND
  • Azima S, Bakhshayesh H.R, Mousavi S, Ashrafizaveh S. Comparison of the effects of reflexology and massage therapy on primary dysmenorrhea. Biomedical Research. 2015; 26 (3): 0976-1683.

    BACKGROUND
  • De Sanctis V, Soliman A, Bernasconi S, Bianchin L, Bona G, Bozzola M, Buzi F, De Sanctis C, Tonini G, Rigon F, Perissinotto E. Primary Dysmenorrhea in Adolescents: Prevalence, Impact and Recent Knowledge. Pediatr Endocrinol Rev. 2015 Dec;13(2):512-20.

    PMID: 26841639BACKGROUND
  • Memmott J. The effect of music-assisted progressive muscle relaxation on the self-reported symptoms of women with primary dysmenorrhoea [PhD thesis]. Kansas: University of Kansas; 2009.

    BACKGROUND
  • Apay SE, Arslan S, Akpinar RB, Celebioglu A. Effect of aromatherapy massage on dysmenorrhea in Turkish students. Pain Manag Nurs. 2012 Dec;13(4):236-40. doi: 10.1016/j.pmn.2010.04.002. Epub 2010 Sep 15.

    PMID: 23158705BACKGROUND
  • İbrahimoğlu Ö, Kanan N. The effect of progressive muscle relaxation exercises after endotracheal extubation on vital signs and anxiety level in open heart surgery patients. Turk Journal Intense Care. 2017; 15(3): 98-106.

    BACKGROUND
  • Mackereth PA, Booth K, Hillier VF, Caress AL. Reflexology and progressive muscle relaxation training for people with multiple sclerosis: a crossover trial. Complement Ther Clin Pract. 2009 Feb;15(1):14-21. doi: 10.1016/j.ctcp.2008.07.002. Epub 2008 Oct 1.

    PMID: 19161949BACKGROUND

MeSH Terms

Conditions

DysmenorrheaPain

Interventions

Massage

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and SymptomsPelvic PainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study was done experimentally in pre-test and post-test design and randomized controlled model among students with PD. The sample size was calculated with power analysis. According to calculations, it was found that 58 students were enough for sampling through 95% of power value, 0.05 of confidence interval and 0.88 of effect size. Students who were determined to meet sampling and inclusion criteria through questionnaire and accepted to participate in the study were assigned into the experimental and control groups through randomization. During the follow-up of the three menstruation periods, the number of groups was increased in case of drop-out and 100 students were included. However, the study was completed with a total of 97 students -50 students for the experimental group and 47 students for the control group- because 3 students of the control group withdrew from the study in the second month.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 16, 2020

First Posted

April 22, 2020

Study Start

May 1, 2017

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

May 12, 2021

Record last verified: 2021-05

Locations