What is the effectiveness of at-home yoga-intervention for women suffering from pain due to endometriosis when compared to no yoga intervention.
ID
Source
Brief title
Condition
- Uterine, pelvic and broad ligament disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain reduction on the numeric rating scale [NRS] after 8 weeks.
A significant reduction in pain score is defined as a mean difference between
groups of at least 1.4 points measured on the NRS.
Secondary outcome
• Quality of life
• Pain Catastrophizing
• Affective Symptoms
• Gastrointestinal symptoms
• Pain reduction after 4 and 12 weeks
• Use of analgesics
• Reduction of dysmenorrhoea (if applicable)
• Reduction of dyspareunia (if applicable)
• The differences in pain reduction assessed by ESM compared to end of day pain
scores and end of week pain scores.
Background summary
Endometriosis related (pain)symptoms have a significant impact on the quality
of life of these women. However, the extent of this disease is not directly
related to the degree of symptoms. The difference in pain presentation and
therapy refractoriness, has led to the suggestion that the perception of these
symptoms may be influenced by psychological and emotional distress. The
literature suggests that affective symptoms like anxiety and depression occur
more often in these patients. Participants with greater self-esteem and
self-efficacy are less distressed and efficient emotion regulation is
associated with the ability to cope with chronic pain. The care of patients
with endometriosis has been complicated by the coronavirus disease pandemic as
healthcare appointments and surgeries are being temporarily postponed. In
combination with medical therapies, or as an alternative, patients are
encouraged to consider self-management strategies to combat endometriosis
symptoms during the pandemic. At-home yoga led by an online instructor may be
useful.
Study objective
What is the effectiveness of at-home yoga-intervention for women suffering from
pain due to endometriosis when compared to no yoga intervention.
Study design
Multicenter randomized trial.
Intervention
At-home online livestream yoga sessions scheduled for 75 minutes once a week
during 8 weeks vs no intervention (control).
Study burden and risks
Yoga is generally considered a safe form of physical activity when performed
properly, under the guidance of a qualified instructor. However, as with other
forms of physical activity, injuries can occur. The most common injuries are
sprains and strains. Serious injuries are rare. The risk of injury associated
with yoga is lower than that for higher impact physical activities.
Participating in this research also means:
- patients fill in different kinds of questionnaires (smartphone app, paper
questionnaires and online questionnaires).
De Run 4600
Veldhoven 5504 DB
NL
De Run 4600
Veldhoven 5504 DB
NL
Listed location countries
Age
Inclusion criteria
• Premenopausal women >= 18 years old.
• Diagnosed with endometriosis (by physical examination, imaging techniques or
laparos-copy).
• Patients who report one of the endometriosis related pain symptoms
dysmenorrhoea, abdominal/pelvic pain or dyspareunia; on average, at least 1 day
per week in the last 3 months, with a minimum average pain score on the
numeric rating scale of 4.
• Ability to understand and speak the Dutch language.
• Owning a smartphone.
• Ability to understand how to utilize the Experience Sampling Method [ESM]
tool.
Exclusion criteria
• Change of hormonal medication during the past one month.
(for example for endometriosis treatment or fertility treatment).
• Surgery planned during the study period.
• Already performing yoga or mindfulness during the past 3 months.
• Any organic explanation for chronic pelvic pain besides endometriosis.
• Pregnancy.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL71244.015.19 |
| Other | NL8113 |
| OMON | NL-OMON22833 |