Goals:1.To estimate the effect size for our primary and secondary outcome measures, allowing us to perform a more reliable power estimate for the actual trial.The primary objective of this pilot study is to determine whether a non-pharmacological…
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
•Amount of used morphine via the PCA-system during the first 3 days after
surgery:
Amount of morphine via the Patient Controlled Analgesia (PCA) system will be
documented in the anesthesia report, medication lists from the recovery room
and nursery department.
Secondary outcome
•Use of all post-operative pain medication:
Type and amount of used pain medication and medication for anxiety symptoms
will be documented daily during the two weeks of the study in the patient diary.
•Pre-operative anxiety state:
will be measured 7 days before intervention (T0) and at the day of the surgery
(T1) using the 6-item APAIS
•Self-rated pain:
will be noted daily in the patient diary using a 10-cm visual analogue scale
(VAS) for pain (ranging from "no pain" to "pain as bad as could possibly be"),
from 7 days before to 7 days after surgery. The first 24 hours after surgery
VAS scores will be noted every 6 hours according to standard care.
•Self-rated recovery:
will be noted daily in the patient diary using a 10-cm visual analogue scale
(VAS) for self-assessed surgical recovery (ranging from "poor" to "excellent"),
during 7 days after surgery.
•Feasibility (compliance to intervention).
Patients will be asked to record their daily experiences with guided imagery
and standard care in the patient diary. A compliance questionnaire is part of
the patient diary. Patients will be called by the pain nurse in the
intervention period prior to the surgery to monitor compliance. . Involved
nurses and medical doctors will be asked to complete an evaluation form about
their opinion of practical use of *guided imagery*
Background summary
In previous prospective studies, psychological stress has been shown to impair
surgical wound healing and increase postoperative pain medication. We aim to
investigate whether guided imagery can reduce pre-operative anxiety, reduce
post-operative pain and use of post-operative pain medication, so it could
improve surgical recovery.
The working hypothesis is that patients who receive a psychological stress
reduction intervention prior to surgery will report lower stress and higher
perceived control, use less pain medication and a better self-reported recovery
than patients who receive standard care alone.
Study objective
Goals:
1.To estimate the effect size for our primary and secondary outcome measures,
allowing us to perform a more reliable power estimate for the actual trial.
The primary objective of this pilot study is to determine whether a
non-pharmacological intervention, i.e. relaxation with guided imagery, added to
the standard perioperative analgesic and anxiolytic pharmacotherapy program,
can reduce post-operative pain medication, post-operative pain, pre-operative
anxiety and induce post-operative recovery, compared to standard care.
2.To gain experience with the feasibility of the peroperative use of guided
imagery as a self-management tool in patients with burn wounds scheduled for
corrective or reconstructive surgery, and to refine it if needed
Study design
A mono-centre randomized controlled pilot study with two parallel groups
Duration 2 weeks
Contact 1 (intake: 6 months-1 week before surgery)
•Information and informed consent
•Screening
•Demographic and anthropometric data
•Classification initial burn / type of surgery
•Prestatification/ randomisation
•Instruction for timelines and patient diary (pain nurse)
Before surgery, 1 week (day -7 till day 0, at home)
•Start guided imagery daily pre-operative exercise 3 (intervention group)
•Start daily patient diary (7 days daily before surgery)
Contents pre-operative patient diary (day -7 till day 0):
-Pain medication, self rated pain (VAS) rest/ exercise, experience,
compliance, adverse events
-At day -7 (T0) and day 0 (T1): APAIS
Contact 2/3 (telephone interview: 7 and 3 days before surgery)
•Compliance CD (intervention group)
•Compliance patient diary
•Adverse events (intervention group)
The day of the surgery= day 0 (at the hospital, T1)
After surgery, 1 week (day 0 till day 7, at home or at the hospital)
•Continue guided imagery daily post-operative exercise 4 (intervention group)
•Continue patient diary (7 days daily after surgery)
•End of study: 7 days after surgery, T2
Contents post-operative patient diary (day 0 till day 7):
-Pain medication self rated pain (VAS) rest/ exercise, self-rated recovery
(VAS) experience, compliance, adverse events
Intervention
Intervention group:
In addition to standard care: Patients are provided a CD of the guided imagery
("Gezonde Verbeelding", Elsevier publisher) to take home and practice once a
day during a period of 7 days before surgery (exercise 3 on the CD) and 7 days
after surgery (exercise 4 on the CD). The exercise will be about 20 minutes in
length each day. The CD has been developed by the Van Praag Institute (VPI)
specifically on the one hand to enhance relaxation and prepare patients for
surgery, and on the other hand to enhance relaxation and recovery after surgery
Control group:
Patients in the control group will receive standard care and no additional
intervention before and after surgery.
Study burden and risks
Patients won't have extra contacts in relation to this research. During the
pre-operative consultancy by the anesthesiologist they receive the extra
information and the research requisites (CD (if randomised), patient diary,
extra patient information, and flow cart).
The intervention group will have a time investment of 20 minutes a day to
practise the exersice from the CD.
Patients are called twice during the intervention period by a project member to
monitor compliance (5 minutes per telephone call)
Patients will have to report daily in the patient diary during the 2 weeks of
the study (pain medication, pain, anxiety, recovery, experiences, compliance
and adverse events), about 5-10 minuts per day.
It is expected there are minimal risks for the intervention group . There are
no knowm adverse events of guided imagery.
Vondellaan 13
1940 EB Beverwijk
NL
Vondellaan 13
1940 EB Beverwijk
NL
Listed location countries
Age
Inclusion criteria
•Written informed consent
•Age >= 18 year
•Patients with previous burn injury with a need for reconstructive or corrective surgery
•Ability to understand and speak the Dutch language
•Accessible by phone
•Access to CD-player at home
Exclusion criteria
•Known contra-indication to medication used in the standard pain- and general anaesthesia protocol (Midazolam, Paracetamol, Diclofenac, Tramadol, Diprivan, Sufentanil, Morphine, Esmeron and Sevofluran)
•Actual psychosis
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 | NL33985.094.10 |