The Effects Of Relaxation Training In Women With Primary Dysmenorrhea

NCT05328869 | Unknown

• 1 other identifier: 2022/04/07
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Primary Dysmenorrhea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Menstrual symptoms

  change from baseline at an average of 2 weeks

• Impacts of academic/work performance

  change from baseline at an average of 2 weeks

• Impacts of life quality

  change from baseline at an average of 2 weeks

• Impacts of social activity

  change from baseline at an average of 2 weeks

• Anxiety level

  change from baseline at an average of 2 weeks

Study Arms (2)

Relaxation group

EXPERIMENTAL

Jacobson progressive relaxation training will be applied

Other: Relaxation training

Control group

OTHER

No intervention will be applied

Other: No intervention

Interventions

Relaxation training OTHER

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

Relaxation group

No intervention OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Primary dysmenorrhea is a gynecological problem that can be seen in most women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

MeSH Terms

Interventions

Relaxation Therapy

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Seyda Toprak Celenay

  Ankara Yildirim Beyazıt University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seyda Toprak Celenay

CONTACT

+90312 906 1000; sydtoprak@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 14, 2022
• Study Start: May 15, 2022
• Primary Completion: October 15, 2022
• Study Completion: December 15, 2022
• Last Updated: April 14, 2022

Record last verified: 2022-04