The Effects Of Relaxation Training In Women With Primary Dysmenorrhea

The aim of this study was to investigate the effects of relaxation training on menstrual pain severity, menstrual symptoms, impact of quality of life, impact of work/academic performance, impact of social activity level and anxiety level in women with primary dysmenorrhea (PD) complaints.

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Dysmenorrhea
• Intervention / Treatment: Other: Relaxation training; Other: No intervention

Detailed Description

PD is the cramping pain that comes before or during a menstrual period. Relaxation training contributes to the reduction of stress and pain. Thus, there is a need to investigate the effects of relaxation training in dysmenorrhea.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women with primary dysmenorrhea complaint according to the Primary Dysmenorrhea Consensus Guide,
• Over 18 years of age,
• Having a mean pain intensity of moderate and higher according to the Visual Analogue Scale in the last 6 months,
• Having a regular menstrual cycle (28±7 days),
• Volunteered to participate in the study.

Exclusion Criteria:

• Having a pathological history and radiological findings pointing to secondary dysmenorrhea,
• Using oral contraceptives/antidepressants at least 6 months,
• Receiving hormone therapy,
• Undergoing pelvic surgery,
• Pregnant,
• Giving birth,
• Using an intrauterine device,
• Having neurological, orthopedic and/or rheumatological diseases
• Having a psychiatric disease,
• Having a history of malignancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Relaxation group; Jacobson progressive relaxation training will be applied	Other: Relaxation training; Relaxation training will be performed under the supervision of a physiotherapist. The training is carried out from the estimated day of ovulation (cycle length in days minus 14) until the next menstrual period begins
Other: Control group; No intervention will be applied	Other: No intervention; No intervention will be applied. The natural process will be followed from the estimated day of ovulation (cycle length in days minus 14) until the next menstrual period begins

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Menstrual pain intensity	Menstrual pain intensity will be evaluated with Visual Analogue Scale. This scale consists of a 10 cm horizontal line. The starting point "0" = "no pain", while "10" = "unbearable pain". Individuals will be asked to mark on a 10 cm straight line according to the level of pain they feel. Pain intensity will be recorded by measuring the distance between the beginning of the line and the marked place.	change from baseline at an average of 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Menstrual symptoms	Menstrual symptoms will be measured with the menstrual symptom questionnaire. Menstrual Symptom Questionnaire is a 24-item self-report scale and each item is scored between 1 (never) and 5 (always). An increase in the mean score indicates an increase in the severity of menstrual symptoms. The total score is 120 points.	change from baseline at an average of 2 weeks
Impacts of academic/work performance	Impacts of academic/work performance will be evaluated with Visual Analogue Scale. This scale consists of a 10 cm horizontal line. The starting point "0"= means "my work/school performance is not affected in any way", while "10"= means "my work/school performance is greatly affected"	change from baseline at an average of 2 weeks
Impacts of life quality	Impacts of life quality will be evaluated with Visual Analogue Scale. This scale consists of a 10 cm horizontal line. The starting point "0" = "my quality of life is not affected in any way", while "10" = "my quality of life is greatly affected". Individuals will be asked to mark on a 10 cm straight line according to the quality of life they think.	change from baseline at an average of 2 weeks
Impacts of social activity	Impacts of social activity will be evaluated with Visual Analogue Scale. This scale consists of a 10 cm horizontal line. The starting point "0" = "my social activity is not affected in any way", while "10" = "my social activity is greatly affected". Individuals will be asked to mark on a 10 cm straight line according to the social activity they think.	change from baseline at an average of 2 weeks
Anxiety level	Anxiety level will be assessed with the Spielberger State Trait Anxiety Inventory. This inventory is a 40-item self-report inventory designed to measure both state anxiety section (current feelings of apprehension, worry, etc.) and trait anxiety section (continuous feelings of apprehension, worry, etc.). Each section is scored on four levels of anxiety intensity from 1="not at all" to 4="very much" and with a sum score between 20 and 80. A higher total score indicates more severe anxiety level.	change from baseline at an average of 2 weeks

Collaborators and Investigators

• Sponsor: Ankara Yildirim Beyazıt University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 15, 2022
• Primary Completion (Anticipated): October 15, 2022
• Study Completion (Anticipated): December 15, 2022

Study Registration Dates

• First Submitted: April 7, 2022
• First Submitted That Met QC Criteria: April 7, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea
• Other Study ID Numbers: 2022/04/07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No