Does mindfulness based cognitive therapy in addition to treatment as usual (TAU) improve QoL compared to TAU alone in patients with CPP based on a hypertonic pelvic floor ?
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
EQ 5D scores to measure QoL
Secondary outcome
NRS scores to measure the level of pain.
PCS scores to measure the sensation of pain.
HADS to measure depression and anxiety.
MAPLe measurements to measure the pelvic floor tension.
Background summary
Chronic pain has a great impact, including on daily functioning. This can be
accompanied by feelings of uncertainty, sadness, anxiety and gloom.
Mindfulness is about being present in the moment. It is about becoming aware of
thoughts and feelings in an accepting and neutral way. In this way, space can
be created to deal with pain symptoms differently, for instance by making
choices that allow you to take better care of yourself.
During the mindfulness training, you practise focusing your attention, for
instance through a sitting meditation or body scan. This teaches you to become
aware of thoughts, feelings and physical sensations, and then learn to distance
yourself from them. This can help break through negative thoughts.
Mindfulness training was originally developed to teach people to cope better
with pain and physical symptoms. Scientific research has shown that mindfulness
training is effective in reducing and learning to cope better with pain.
Study objective
Does mindfulness based cognitive therapy in addition to treatment as usual
(TAU) improve QoL compared to TAU alone in patients with CPP based on a
hypertonic pelvic floor ?
Study design
Pilot study in the form of a randomized controlled trial
Intervention
The intervention group receives mindfulness based cognitive therapy in addition
to treatment as usual (TAU).
The control group receives treatment as usual (TAU) alone.
Study burden and risks
The burden for subjects in this study consists of extra visits to Radboudumc to
receive mindfulness based therapy. There are no risks associated with this
therapy. All additional operations are part of regular care for similar (pain)
conditions.
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
Female patients with chronic pelvic pain caused by a hypertonic pelvic floor
Exclusion criteria
Patients < 18 years of age
Incapacitated subjects
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL86058.091.24 |