Effect of a Semi-Presence Yoga Program on Primary Dysmenorrhea

NCT04295954 | Unknown

• 1 other identifier: DISMYOGA01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effectiveness of a blended learning yoga program using virtually tutored home follow-up on pain intensity measured using the VAS scale, quality of life and adherence among nursing students with moderate to severe dysmenorrhea, compared to a control group of students. Half of the women involved will receive a yoga intervention for dysmenorrhea for 12 weeks, while the other half will continue with their conventional treatment during the same period. The results of the evaluations carried out prior, to the month, 3 months, 6 and 12 months of the intervention will be compared.

Conditions

Dysmenorrhea Primary; Pain, Menstrual; Yoga

Keywords

clinical trial protocol; exercise therapy; quality of life; exercise movements technique; female

Outcome Measures

Primary Outcomes (2)

• Changes in Pain Intensity

  Pain intensity will be assessed with the Visual Analog Pain Scale (VAS): Is a continuous scale consisting of a horizontal line of 10 centimeters (100 mm) in length, ranging "painless" (score of 0) to "pain as severe as it could be" or "worst imaginable pain" (score of 100).

  Change from baseline pain intensity at 1 month; Change from baseline pain intensity at 3 months; Change from baseline pain intensity at 6 months; Change from baseline pain intensity at 12 months;

• Changes in Satisfaction and Quality of life

  Quality of life will be evaluated with the SF-12 Abbreviated Quality of Life Questionnaire, with consists of 12 quality of life items measured o a Likert scale between 0 and 6. Explore multidimensional health and self-administer.

  Change from baseline Quality of Life at 1 month; Changes from baseline Quality of Life at 3 months; Changes from baseline Quality of Life at 6 months; Changes from baseline Quality of Life at 12 months.

Secondary Outcomes (9)

• Sleep quality

  baseline,1 month, 3 months, 6 months, 12 months

• Degree of drowsiness

  baseline, 1 month, 3 months, 6 months, 12 months

• Anxiety State

  baseline, 1 month, 3 months, 6 months, 12 months

• Anxiety Traits

  baseline, 1 month, 3 months, 6 months, 12 months

• Stress

  baseline, 1 month, 3 months, 6 months, 12 months

Study Arms (2)

Yoga Intervention

EXPERIMENTAL

This group will receive the Yoga Intervention for dysmenorrhea that will consist of 3 yoga sessions a week of 30 minutes each, for 12 weeks. The first 4 weeks 1 of the sessions will be face to face and the other 2 home sessions guided by a vieo and a brochure, and tutored from the virtual platform by the yoga teacher and researchers. This space will also serve for participants to share experiences. After the first 4 weeks, participants will continue with the virtually tutored home yoga program, consisting of 3 weekly sessions of 30 minutes until completing the 12 weeks. They will be protected in all cases by the teacher and researchers. All intervention group participants will be invited to participate in online focus groups during week 12 to explore their experiences and satisfaction with the progress of the study and to implement adaptations, if necessary. They will be evaluated before the start of the yoga program per month, 3 months, 6 months and a year after the intervention.

Other: Yoga Intervention

Control group without intervention

NO INTERVENTION

Participants in the comparison group without intervention will not receive yoga intervention, will follow their conventional treatment and their usual daily activities. They will be told not to do yoga. They will be evaluated in advance, per a month, 3 months, 6 months and a year after the intervention.

Interventions

Yoga Intervention OTHER

It is an intervention based on Hatha yoga designed specifically to improve dysmenorrhea. This intervention consists of physical postures, also called asanas; meditation and breathing. It begins with a progression of various asanas until reaching the three central postures: "cat, cobra and fish". The compensation asanas of these central postures are then performed, and it is closed with a relaxation. The program and Yoga Intervention have been triangulated by experts and piloted afterwards.

Yoga Intervention

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: female, nulliparous
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Nulliparous women who exhibit moderate-severe pain, 4-10 according to VAS, associated with menstruation in their last cycle, have no history of diagnosed gynecological pathology, and have an internet access device (mobile, computer or table).

Sponsors & Collaborators

• University of Huelva: lead

Study Sites (1)

Ana Abreu Sánchez

Huelva, Andalusia, 21001, Spain

Location

Related Publications (25)

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MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ana Abreu Sánchez, PhD

  Universidad de Huelva, Facultad de Enfermería

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assignment to groups will be blind. A random number computer application will be awarded each participant to a group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teacher and Researcher

Model Details: Two groups will be formed with women who meet the inclusion criteria. Each participant will be randomly assigned to each group, receiving different treatment depending on the group in which it has been assigned: the intervention group will receive yoga intervention and the control group will continue with its conventional treatment for the dysmenorrhea.

Study Record Dates

• First Submitted: February 26, 2020
• First Posted: March 5, 2020
• Study Start: October 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: October 1, 2021
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)