Pain control in patients with endometriosis through relaxation methods and activity exercises supported by virtual reality technology

Not Applicable

• Conditions: N80; Endometriosis

• Registration Number: DRKS00030189
• Lead Sponsor: Department für Frauengesundheit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-22
• Study Completion: 2023-03-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 23

Inclusion Criteria

Age over 18.
-Severe pain reported in clinical routine (minimum of 5 points on NRS scale).
-Willingness not to schedule surgery or start a new analgesic (non-opioid and opioid analgesics) during participation in the study (except for established emergency medication).
-Willingness not to start a new non-drug treatment such as acupuncture, behavioral therapy, massage. If such therapy exists, it should be continued unchanged
-Signed patient information and consent form
-Understanding of the German language, ability to consent and compliance
-The patient has understood the principle of the patient diary and agrees to keep it according to the instructions and to use the VR glasses according to the instructions.

Exclusion Criteria

-Start of regular use of opioid analgesics within 7 days prior to study entry.
-Serious mental illness (e.g., psychosis, schizophrenia, bipolar disorder), major depression, screening using the questionnaires, DASS (determining the likelihood of the presence of a depressive disorder or anxiety disorder.
-Epilepsy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The average pain intensity during the day and the maximum pain intensity during the day measured by the NRS scale from 0-10 <br>Daily, throughout the entire study period (14 week of intervention): Daily record (the average pain intensity, max. pain intensity, on- demand medication), using the pain e-diary<br>

Secondary Outcome Measures

Name	Time	Method
1.Pain-related impairment as measured by the PDI score improves by 20%<br>2.Improvement in general health-related quality of life measured by the SF 12 <br>3.Sleep quality improves as measured by the MOS-SS<br>