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Visual distraction to reduce anxiety and pain during nerve block injection

Effectiveness of an audio-visual device for anxiety and pain reduction during a nerve block procedure – a randomized controlled trial

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN84820314
Enrollment
195
Registered
2021-07-06
Start date
2018-06-20
Completion date
Unknown
Last updated
2021-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain and anxiety before and during a nerve block procedure Not Applicable Anxiety before and during a medical procedure, pain

Interventions

Patients were randomly assigned (block size three) to one of the three intervention groups by computer program Research Manager, Deventer, The Netherlands, 2018. General preoperative characteristics w

Sponsors

Spaarne Gasthuis
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adults 18 years and older 2. Conditions that require nerve block intervention 3. Written informed consent 4. We allow re-enrolment in the randomisation procedure, as some patients will return for repeated treatment during the randomisation period. A new written informed consent is needed

Exclusion criteria

Exclusion criteria: 1. Patients with difficulties in speaking and reading Dutch 2. Patients physically or mentally not able to consent 3. Patients with severe hearing loss or refraction errors making it impossible to wear the audiovisual device 4. Anxiety disorders, such as panic disorder, obsessive-compulsive disorder, posttraumatic stress disorder and others 5. ASA 4 - 5

Design outcomes

Primary

MeasureTime frame
Anxiety assessed with the Dutch State and Trait Anxiety Inventory (STAI) form before (T1) and after (T2) the medical procedure

Secondary

MeasureTime frame
1. The Numeric Rating Scale (NRS) was used for measuring pain on a 0 -10 scale at T1 and T2 2. Electrodermal activity (EDA) sensor PIP, Dublin, Ireland 2018, was placed during the medical treatment only, recording EDA in frames of 8 times per second to determine stress levels and stress events during the procedure 3. Experiences of the intervention measured using a novel questionnaire at T2 4. Side effects reported on the questionnaire by the patients or noted by the medical staff at T2

Countries

Netherlands

Contacts

Public ContactKarlijn van Stralen
kvanstralen@spaarnegasthuis.nl+31 232241681

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026