The main objective of this study is to investigate whether a music intervention as complementary treatment is effective in reducing anxiety and distress around surgery. Secondary objectives are effects of music on pain, on preoperative anxiety, on…
ID
Source
Brief title
Condition
- Penile and scrotal disorders (excl infections and inflammations)
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study outcome is distress intensity assessed with the Comfort-B scale.
Preoperative anxiety at induction and physiological parameters such as blood
pressure are secondary outcome parameters to assess physiological stress. Also,
the amount of postoperative pain and possible relation of distress in children
regarding to distress in their parents are secondary parameters.
Secondary outcome
The use of music as intervention has no known deleterious effects on patients.
Safety precautions will be taken to limit the volume of the music on
headphones. Patients in all study arms will receive standard perioperative
care. Burden includes the completion of several questionnaires and two
measurements of heart rate by parents. Measurements of vital signs will be
collected from normal care data. No extra site visits will be necessary for
participation in this study. This research is performed in minors, as the
additive value of this intervention in these age groups has not been
sufficiently studied.
Background summary
This study will investigate the effects of a music intervention on distress,
anxiety and pain in 0-to-3-year-old infants undergoing surgery. Studies in
adult patients found that music interventions prior to surgery can alleviate
anxiety and distress surrounding surgery. Music interventions during surgery,
either when the patient is awake or asleep, can also reduce physiological
stress, anxiety and postoperative pain. In this study, we will investigate the
hypothesis that music interventions prior to and during surgery will result in
less anxiety and distress in infants undergoing surgical procedures.
Study objective
The main objective of this study is to investigate whether a music intervention
as complementary treatment is effective in reducing anxiety and distress around
surgery. Secondary objectives are effects of music on pain, on preoperative
anxiety, on physiological parameters such as blood pressure and on the amount
of required analgesics. Possible relation of distress in children regarding to
distress in their parents is investigated.
Study design
This study will be performed as a randomized controlled intervention study.
Intervention
Patients will be allocated to one of three study arms. The patients in the
first study arm will receive both pre-operative and intraoperative music
intervention; the patients in the second study arm will only receive
preoperative music intervention; the patients in the third study arm will
receive no intervention and serve as control group. All subjects will wear
headphones during surgery. Subjects will listen to an appropriate music
intervention consisting of string instruments, as reported in literature and
recommended by music therapists.
Study burden and risks
Subjects will be filmed for 5 or 6 times during 2 minutes, for afterwards
evaluation of the Comfort-assessment and modified Yale preoperative anxiety
scaleby a trained observer. Subjects will also be filmed during the
pre-operative music intervention. All films will be deleted at the end of the
study. Burden is minimal. Parents of subjects will be asked for participation
in 3 questionnaires, which will take 3-5 minutes for each questionnaire. Their
heart rate will be measured twice.
There are no known deleterious effects of listening to music. Annualy, many
surgeries are performed in this patientpopulation. This simple,
non-pharmacological intervention might easily reduce anxiety and discomfort
around surgeries in this patient population.
Wytemaweg 80
Rotterdam 3015CN
NL
Wytemaweg 80
Rotterdam 3015CN
NL
Listed location countries
Age
Inclusion criteria
- Age 0-3 years (inclusively 3 years)
- Scheduled for surgery for inguinal hernia (uni- or bilateral), undescended testicle (uni- or bilateral), hypospadias
- American Society of Anesthesiologists (ASA) physical status 1 and 2
- General anaesthesia with caudal block
- Parents good knowledge of the Dutch or English language
- Signed informed consent
Exclusion criteria
- Age * 4 years
- Hearing impairments
- Emergency surgery
- Premedication with midazolam
- Impaired communication with parents
- Difficulties in speaking and reading Dutch or English in parents
- Missing informed consent
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 | NL53900.078.15 |