Visual distraction to reduce anxiety and pain during nerve block injection
| ISRCTN | ISRCTN84820314 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84820314 |
| Secondary identifying numbers | 2018.273 |
- Submission date
- 17/12/2020
- Registration date
- 06/07/2021
- Last edited
- 08/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
A visit to the hospital for a medical procedure increases tension and emotion in many people. This is very understandable, which is why we are now investigating whether we can make a person’s stay in the hospital more pleasant by using video glasses during the treatment.
A nerve block is an injection of a local anaesthetic to numb the nerves supplying a particular part of the body, such as the hand, arm or leg.
How much fear/pain someone experiences during a nerve block differs per person. By using the video glasses, we hope to be able to provide sufficient distraction to experience less fear and/or pain during the treatment.
Who can participate?
Adults over 18 years, who are going to undergo a nerve block at the hospital
What does the study involve?
The video glasses are a kind of glasses with headphones that allow you to watch and listen to a video during the treatment.
Participants will be assigned at random (by the computer) to one of the three research groups.
Group 1 standard treatment, with video glasses on during the treatment and a maximum of 5 minutes before the treatment to get used to the glasses and headphones.
Group 2 standard treatment, with video glasses on during the treatment but also 15 minutes before the treatment to completely unwind and relax.
Group 3 standard treatment, without using the video glasses (this is the current treatment currently being given in the hospital).
What are the possible benefits and risks of participating?
Patients will not directly benefit from participating in this study, apart from a potential reduction in pain. Disadvantages to participation will be 10 mins taken to complete questionnaires and an additional 15 mins for one of the treatment groups before the start of the treatment.
Where is the study run from?
Spaarne Gasthuis (Netherlands)
When is the study starting and how long is it expected to run for?
From March 2018 to February 2019
Who is funding the study?
Spaarne Gasthuis (Netherlands)
Who is the main contact?
Dr Karlijn van Stralen
kvanstralen@spaarnegasthuis.nl
Contact information
Public
Spaarne Gasthuis - wetenschapsbureau
Spaarnepoort 1
Hoofddorp
2300RC
Netherlands
 ORCID ID |
0000-0002-3243-2970 |
|---|---|
| Phone | +31 232241681 |
| kvanstralen@spaarnegasthuis.nl |
Study information
| Study design | Parallel group non-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | ISRCTN84820314_PIS_English_16 Nov20.pdf |
| Scientific title | Effectiveness of an audio-visual device for anxiety and pain reduction during a nerve block procedure – a randomized controlled trial |
| Study hypothesis | The audio-visual device will influence the amount of experienced anxiety and pain during a pain relief procedure. In addition, we expect that patients will benefit when the distraction starts prior to treatment; by attenuating anxiety beforehand, affecting the perceived procedural pain.21 |
| Ethics approval(s) | The Medical Ethics review committee of the VU University Medical Center (OHRP - IRB00002991/FWA00017598) judged on June 5, 2018, that the medical research involving human subjects ACT (WMO) does not apply to this study as the intervention was not considered medical, as all patients received standard care and the intervention was the use of video glasses. They stated that this study did not require official approval by the committee. (2018.273). Approved 05/07/2018, institutional review board of the spaarne gasthuis (Spaarne Poort 1, Hoofddorp, Netherlands 2134 TM; +31 (023) 22 42842; no email contact available), ref: 2018.0055. |
| Condition | Pain and anxiety before and during a nerve block procedure |
| Intervention | 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 were provided by the participants at home or in the waiting area of the clinic. In the holding area room, all the participants scored their levels of anxiety and pain for that particular moment in time (T1). After that, instructions on how to use the video glasses were provided for group 1 and 2. Group 1 underwent the medical procedure with the glasses on. Group 2 had an extra 15 min in the holding area ‘to relax’ with the video glasses on while watching their video of preference and continued watching the video during the medical procedure. Group 3 underwent the medical procedure as usual, without video glasses. Normal duration of the medical procedure was 10-12 min. After the medical procedure, all patients were moved to the recovery room where T2 was scored. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Video glasses |
| Primary outcome measure | Anxiety assessed with the Dutch State and Trait Anxiety Inventory (STAI) form before (T1) and after (T2) the medical procedure |
| Secondary outcome measures | 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 |
| Overall study start date | 06/03/2018 |
| Overall study end date | 02/02/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 195 |
| Total final enrolment | 99 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 20/06/2018 |
| Recruitment end date | 02/02/2019 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Hoofddorp
2300RC
Netherlands
Sponsor information
Hospital/treatment centre
Spaarne Poort 1
Hoofddorp
2300 RC
Netherlands
| Phone | +31 22416444 |
|---|---|
| wetenschapsbureau@spaarnegasthuis.nl |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/01/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We aim to publish our paper in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Karlijn van Stralen (wetenschapsbureau@spaarnegasthuis.nl). The R dataset will be available until December 2032. Approval for use of dataset is required from the local review board of the Spaarne Gasthuis, as well as the legal department to check if the data request falls within the consent of the participants. This depends on the required data, the country of the request, and the location of the analyses. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 16/11/2020 | 08/07/2021 | No | Yes | |
| Protocol file | 04/05/2018 | 08/07/2021 | No | No |
Additional files
- ISRCTN84820314_PROTOCOL_04May2018.pdf
- Uploaded 08/07/2021
- ISRCTN84820314_PIS_English_16 Nov20.pdf
- Uploaded 08/07/2021
Editorial Notes
08/07/2021: The participant information sheet has been uploaded. Uploaded protocol 04 May 2018 (not peer reviewed).
06/07/2021: Trial’s existence confirmed by the Medical Ethics review committee of the VU University Medical Center.
