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van CCT (UK)

van CCT (UK)

The effect of music as a preoperative anxiety-reducing aid

- candidate number15316
- NTR NumberNTR4138
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-aug-2013
- Secondary IDs  METC St. Elisabethziekenhuis Tilburg
- Public TitleThe effect of music as a preoperative anxiety-reducing aid
- Scientific TitleThe effect of coping and sense of control on the anxiety-reducing effect of music on preoperative anxiety
- hypothesisPreoperative anxiety can cause a range of negative outcome effects in the perioperative fase, e.g. hgher consumption of medication, more pain, prolonged stay at hospital and more postoperative infections. Music as a anxiety reducing aid in the preoperative fase has proven to be effective. But there is still no consensus on which music is most effective (selfchosen or calming music) Are coping strategies and sense of controle of patients related to the kind of music that is applied in the preoperative fase. Problem-focused coping strategies relate to more sense of control and therefore self-chosen music is more effective in anxiety reduction. Emotion-focused coping strategies are therefore more effective when calming music is offered in the preoperative fase. We expect that music is anxiety reducing, especially when the kind of music is meeting the needs of the patient.
- Healt Condition(s) or Problem(s) studiedCoping, Sense of control, Music intervention, Preoperative anxiety
- Inclusion criteria1. patients over 18 year
2. daycare patients
3. speaking Dutch language
- Exclusion criteria1. mental diseases
2. diseases that influence heartrate and bloodpressure
3. medication that influence heartrate and bloodpressure
4. vision difficulties
5. hearing difficulties
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2013
- planned closingdate31-dec-2013
- Target number of participants200
- InterventionsPatient are at-random allocated to one of the three intervention groups:
1. self-chosen music
2. calming music
3. control group/ no music/ care-as-usual
When patient arrive at the holding of the OR, the listing to music by headphones. The control-group receive care-as-usual. The music continues at the arrival of the OR. Just after the anesthetics are injected the music intervention stops.
- Primary outcomeHeartrate: t0, t1,t2,t3
Bloodpressure: t0, t1,t2,t3
Skintemperature: t1,t2,t3
VAS-anxiety: t0, t1,t2,t3
VAS-controle: t0,t1,t2,t3
VAS-pain: t3
Coping strategy: t0
Preoperative anxiety anesthetic: t0
preoperative anxiety surgery: t0
need for information anesthetic; t0
need for information anesthetic: t0
- Secondary outcomequalitative interview with musictherapist, main experience music intervention.
- Timepointst0; PPO outpatients
t1: arrival holding OR
t2: arrival OR
t3: arrival daycare centre
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator Open University of the Netherlands, Faculty of Psychology, St. Elisabeth Hospital, Tilburg
- Funding
(Source(s) of Monetary or Material Support)
Self Funding
- PublicationsN/A
- Brief summaryThis research is taken place in the St. Elisabeth Hospital in Tilburg The Netherlands, assigning a Master Thesis Health Psychology at the Open University Heerlen Netherlands.

In most cases ongoing surgery will cause an amount of anxiety within the patient. Listening to music in the preoperative fase can have an anxietyreducing effect. Some researchers state that self-chosen music is most effective, others state that calming-music is most effective. Perhaps copingstrategies give an answer to the question which type of music is most effective.

Daycare patients premedicated with benzodiazepines sometimes have a prolonged stay at daycare centre. This is a negative side effect. Music can be a alternative to premedication because of its anxiety reducing effects. When this music is offered more custom-made, suited to the patients copingstrategy, it will be more beneficial to patient and hospital.

Study design
200 participants allocated at-random to one of the 3 groups: 1. Self-chosen music.2. calming music. 3. Controle group/ care-as-usual/no music Measurements t0, t1, t2, t3: Several physiological and psychological parameters of anxiety were measured four times. Heartrate, bloodpressure, skintemperature, Visual Analoge Scale-anxiety, VAS-sense of control, Amsterdam Preoperative Anxiety Information Scale. Coping was measured with Coping Inventory Stressful Situations-NL. And pain with VAS-pain (t3)

Study population
Day-care patients over 18 years old, understanding Dutch language. Excluding patients with mental diseases, patients with diseases that influence directly HR and BB, patients who take medication that influence HR and BB, visual and/or hearing limitations.

First measurement of BB and HR at the PPO screening. At home daycare patient fill out the questionnaire they received at de PPO screening ( it includes VAS, APAIS, CISS-Nl). Within several weeks the daycare patients undergoing surgery arrive at the holding of the OR. After scoring VAS and measuring BB and HR they listen to music(self-chosen or calming) with a headphone. Controle group doesn’t receive music, but care-as-usual. At some point the patient is transported tor he OR. Music is continuated at the OR. The Third measurements are taken place just before the anesthetics are injected. The patient scores VAS, and BB and HR are registered. Postoperative at the daycare centre the fourth measurements are taken place.
- Main changes (audit trail)
- RECORD25-aug-2013 - 4-sep-2013

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