Primary objective: to investigate which independent variables (gender, age, abdominal pain during previous month, previous abdominal surgery, fear, locus of control, coping and focused attention) were related to the patients which are able to…
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
a) the percentage of patients that is able to undergo colonoscopy with VR and
without sedation up to the moment that the scoop reach the coecum, b) the
identification of independent variables related to this percentage.
Secondary outcome
a) the score for the overall pain level, b) the score for the pain level at the
most painful moment, c) the score for the overall patients satisfaction level,
d) the score for the overall doctors satisfaction level, e) the identification
of independent variables related to the overall pain level and f) the
identification of independent variables related to the overall patients
satisfaction level.
Background summary
The final aim of using VR during colonoscopies, is to make unsedated
colonoscopies more comfortable, to benefit the advantages of unsedated
colonoscopies and to enlarge the amount of unsedated colonoscopies. Following
the ongoing questionnaire (MEC 2013-42) and the finished pilot (RTPO-893), the
current study will investigate which patients will benefit most from the effect
of VR during colonoscopies.
Study objective
Primary objective: to investigate which independent variables (gender, age,
abdominal pain during previous month, previous abdominal surgery, fear, locus
of control, coping and focused attention) were related to the patients which
are able to undergo coloscopie with VR and without sedation up to the moment
that the scoop reach the coecum.
Secundary objective: to investigate the level of pain and satisfaction and
which independent variables were related with the level of pain and
satisfaction.
Study design
Based on the inclusion and exclusion criteria, the gastroenterologist selects
the patients who are eligible for participation in this study. All participants
undergo the same procedure. Data is gathered by questionnaires, attention task
and observation.
Study burden and risks
Because no sedation is used, there are no side effects related to the use of
sedation. Thereby the recovery time is shorter, daily activities can be resumed
earlier and patients can participate in traffic independently. Also costs for
healthcare are lower because no sedation is used.
In addition to a certain time investment, the risico exists that the pain
relief is insufficiënt by using VR and undergoing colonoscopy is (too) painful.
Therefore, the possibility exists to ask for sedation during colonoscopy.
Van Swietenplein 1 Van Swietenplein 1
Groningen 9728NT
NL
Van Swietenplein 1 Van Swietenplein 1
Groningen 9728NT
NL
Listed location countries
Age
Inclusion criteria
Age 18 years and older
Scheduled for colonoscopy
Mentally competent
Dutch speaking, reading and writing
Approval of attending physician
Exclusion criteria
Severe comorbidity
Pregnant
Colonic stenosis
Physical limitations
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 | NL53709.099.15 |