The Effects Of Relaxation Training In Women With Primary Dysmenorrhea

Primary Dysmenorrhea Clinical Trial

Official title:

The Effects Of Relaxation Training In Women With Primary Dysmenorrhea

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05328869
• Other study ID #: 2022/04/07
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 15, 2022
• Est. completion date: December 15, 2022

Study information

• Verified date: April 2022
• Source: Ankara Yildirim Beyazit University
• Contact: Seyda Toprak Celenay
• Phone: +90312 906 1000
• Email: sydtoprak[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 15, 2022
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Yildirim Beyazit University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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