NCT06225102

Brief Summary

In this study, it was aimed to determine the effect of kegel exercise on menstruation symptoms, severity of dysmenorrheic symptoms and quality of life in nursing students with primary dysmenorrhea. The study was conducted as a single-blind randomized controlled trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

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

March 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
Last Updated

January 25, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

January 13, 2024

Last Update Submit

January 23, 2024

Conditions

Keywords

PRIMARY DYSMENORHEAKegel exerciseNursing studentsExercise

Outcome Measures

Primary Outcomes (5)

  • Personal Information Form

    It was prepared in line with the literature. The form consists of a total of 25 questions, including information about socio-demographic information, pain during menstrual period, vaginal discharge characteristics, and practices regarding menstrual quantity.

    one week

  • Visual Analogue Scale

    It was used to evaluate the pain intensity of individuals during their menstrual period. Individuals were asked to mark their pain level on a 10-centimeter (cm) horizontal line, meaning "0 (no pain)" and "10 (most severe pain)." Individuals responded by thinking about the pain they experienced during the first 3 days of their first, second, and third menstrual cycles.

    one week

  • The Menstrual Symptom Scale

    The scale consists of 22 items and is a five-point Likert type. Items 1-13 belong to "Negative effects/somatic complaints" sub-dimension, items 14-19 belong to "Menstrual pain symptoms" sub-dimension and items 20-22 belong to "Coping methods" sub-dimension. The Menstrual Symptom Scale score is calculated by averaging the total score of the items in the scale. Participants are asked to assign a number between 1 (never) and 5 (always) to the symptoms they experience related to menstruation. An increase in the mean score indicates an increase in the severity of menstrual symptoms. The scale has three sub-dimensions. The score obtained from the sub-dimensions is calculated by averaging the total score of the items in the sub-dimensions. An increase in the mean score for the sub-dimensions indicates an increase in the severity of menstrual symptoms related to that sub-dimension. Cronbach's Alpha value of the scale is 0.86

    Three months

  • The Severity of Dysmenorrheic Symptoms

    The presence and magnitude of dysmenorrhoeic symptoms were assessed using this Likert-type scale (none = 0; mild = 1; moderate = 2; and severe = 3). The dimensions assessed by the scale are: Colicky pain in the lower abdomen, bloating, irritability, depression pain or tenderness in the breasts, back pain, gastrointestinal disorders headache, leg oedema

    Three months

  • The Quality of Life Scale

    Item-total score correlations were calculated between 0.47-0.88. It is not possible to obtain a total score for the Short Form-36 quality of life scale. Instead, summary scores can be obtained for the physical and mental components of health in the Short Form-36 scale. Physical health components are physical function, physical role, pain and general health perception subscales, while mental health components are vitality, social function, emotional role and mental health subscales. In the summary scores, the lowest score is "0" and the highest score is "100" and a high score indicates good health status.

    Three months

Study Arms (2)

experimental group

EXPERIMENTAL

The intervention group was first given training on the definition of kegel exercises, diagnostic criteria, treatment, benefits and how to do kegel exercises on the Zoom platform. A second meeting was held for the participants of the initiative group who could not attend this training. At the same time, a message was sent to the WhatsApp application group where the intervention group was located three times a day by the researchers to remind them to do kegel exercises in the morning, noon and evening.

Behavioral: Kegel Exercise

control group

NO INTERVENTION

No intervention was made in the control group

Interventions

Kegel ExerciseBEHAVIORAL

* Before teaching Kegel exercises, it was recommended that the person empty his bladder and wear comfortable clothing. * It was said that the person should extend his legs straight while exercising and not to contract his leg, hip and abdominal muscles and not to hold his breath while the pelvic floor muscles contract. * The relevant muscles were told to contract for 10 seconds and then relax for 10 seconds. The person was also asked to do the exercises during daily activities. * Exercise was implemented regularly 3 times a day (minimum 30-45 exercises) in the morning, noon and evening.

experimental group

Eligibility Criteria

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

You may qualify if:

  • be between the ages of 18-25
  • Giving 6 points or more to the least menstruation pain on the day that individuals experience the most severe dysmenorrhea symptoms (VAS) out of 10 points on the VAS Visual Pain Scale
  • Being Nulliparous (never giving birth)
  • Regular menstruation for the last six months
  • Not having any gynecological diagnosis
  • Not having had a gynecological operation
  • Volunteering to participate in the study

You may not qualify if:

  • Being a man
  • Being married
  • Being diagnosed with secondary dysmenorrhea
  • Giving menstruation pain less than 6 points out of 10 on the VAS Visual Pain Scale.
  • Taking painkillers 12 hours before the assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gümüşhane University, Faculty of Health Sciences, Department of Nursing

Gümüşhane, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • RUVEYDE AYDIN

    Ondokuz Mayıs University

    PRINCIPAL INVESTIGATOR
  • ÖZGE PALANCI AY

    Gümüşhane Universıty

    PRINCIPAL INVESTIGATOR
  • SONGÜL AKTAŞ

    Karadeniz Technical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
While it is known by the researchers that the students are in the experimental and control groups, it is not known by the students.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The sample of the study consisted of 89 nursing students with primary dysmenorrhea (45 experimental group and 44 control group)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RESEARCH ASSISTANT

Study Record Dates

First Submitted

January 13, 2024

First Posted

January 25, 2024

Study Start

March 1, 2021

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

January 25, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations