Kinesiological Taping and Aerobic Exercise in Women With Primary Dysmenorrhea:

NCT04856280 | Completed DMC

• 1 other identifier: KinesioExercisePD2021
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Dysmenorrhea is defined as the pain and discomfort of women during the menstrual period. Kinesiological taping (KT) and aerobic exercise (AE) are effective methods for dysmenorrhea. The purpose of this study is to investigate the effects of KT and AE on pain, attitude, depression, and quality of life in women with dysmenorrhoea. Forty-five women with dysmenorrhea wıll randomly be divided into three groups as KT group (n=15), AE group (n=15) and control group (n=15). In KT Group, 6 sessions of KT will be applied, starting on the 14th day of the menstrual cycle and 2 times per week for 3 weeks until the end of the cycle. In the AE group, walking and climbing stairs will be given during the menstrual cycle, 3 days a week, 45 minutes. No application will be applied to the control group. All groups will be evaluated with Beck Depression Scale (BDS), Mcgill Pain Questionnaire (MPQ), Menstrual Attitude Scale (MAS), and Short Form- 36 (SF-36) before and after the intervention.

Conditions

Primary Dysmenorrhea; Kinesics; Aerobic Exercise

Keywords

Primary Dysmenorrhea; Kinesiological Taping; Aerobic Exercise

Outcome Measures

Primary Outcomes (2)

• Mcgill Pain Questionnaire

  This questionnaire consists of 11 words to determine the sensory state of pain, and 15 words related to the quality of pain in total, consisting of 4 different words to determine its affective aspect. In addition, the pain intensity felt during measurement is measured by Visual analog Scale (VAS), and the total pain intensity assessed is measured by a 6-point Likert-type scale. In this scale, "0" is defined as no pain, "5" is defined as unbearable pain.

  4 weeks

• Menstrual Attitude Scale

  The scale was prepared based on the theory that there may be versatility in menstrual attitudes, positive attitudes may occur as well as negative, and expectations that may occur according to physiological and emotional symptoms before or during menstruation may be effective in the behaviors shown in this period. Menstrual Attitude Scale (MAS) contains 33 items to measure the positive and negative attitudes of menstruation. MAS has 5 subscales such as the menstruation as a weakening phenomenon (12 no pain, unbearable pain, 32 items), the menstruation as a disturbing phenomenon (6 items), the menstruation as a natural phenomenon (5 items), the predicting/sensing that there will be menstruation (5 items), and the denying the effects of menstruation (7 items). The scale is of 5-point Likert type. The high average score of the subscales shows that the attitude towards menstruation is "positive"

  4 weeks

Secondary Outcomes (2)

• Beck Depression Scale

  4 weeks

• Short Form- 36

  4 weeks

Study Arms (3)

The kinesiological taping (KT) group (n=15)

EXPERIMENTAL

6 sessions of taping was applied to the kinesiological taping group, starting on the 14th day of the menstrual cycle and 2 times a week for 3 weeks until the cycle ended. Using the KT ligament technique, it was applied to the supra pubic region with 100% tension in order to reduce contraction in the uterus

Behavioral: Kinesiological taping

The aerobic exercise (AE) group (n=15)

ACTIVE COMPARATOR

In the AE group, walking and climbing stairs were given during the menstrual cycle, 45 minutes session per day, 3 days a week over 3 weeks. The exercise protocol consists of 5 minute warm up, 35 min AE and 5 minute cool-down exercises. Warm-up and cool-down exercises include an active range of motion (ROM) exercises for upper and lower extremity. Aerobic exercise includes 30 min of moderate walking and climbing stairs. The aerobic exercise was performed in accordance with the definition of moderate-intensity exercise of the World Health Organization; "It was given to the participants that during moderate exercise, the individual should walk with a tempo in a way that he can speak but cannot sing"

Behavioral: Aerobic exercise

The control group (n=15)

NO INTERVENTION

No intervention was applied to the control group.

Interventions

Kinesiological taping BEHAVIORAL

In KT Group, 6 sessions of KT were applied, starting on the 14th day of the menstrual cycle and 2 times a week for 3 weeks until the cycle ended.

The kinesiological taping (KT) group (n=15)

Aerobic exercise BEHAVIORAL

In the AE group, walking and climbing stairs were given during the menstrual cycle, 3 days a week, 45 minutes.

The aerobic exercise (AE) group (n=15)

Eligibility Criteria

• Age: 15 Years - 30 Years
• Gender Eligibility Details: healthy young women who have primary dysmenorrhoea
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Being in the age range of 15-30
• Not being married
• Women with abdominal pain during menstruation 5 and above according to the Visual Analogue Scale.
• Women whose menstrual cycle has started and those whose cycle continues.

You may not qualify if:

• Endometriosis and adenomyosis
• Myoma
• Endometrial polyp
• Previous pelvic infections
• Intrauterine device use
• Venous congestion in the internal genital organs

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, 34815, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Kinesics

Interventions

Exercise

Condition Hierarchy (Ancestors)

Nonverbal Communication; Communication; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Miray BUDAK

  Medipol University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes Assessor was blinded regarding group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 23, 2021
• Study Start: November 22, 2019
• Primary Completion: June 14, 2020
• Study Completion: July 20, 2020
• Last Updated: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)