Evaluation of Interventions to Improve Pain Relief, Perceived Anxiety and Recovery in Participants Receiving Office Based Surgery
Evaluation of an Intervention to Increase Pain Relief, Perceived Anxiety and Recovery in Participants Receiving Office Based Surgery
1 other identifier
interventional
404
1 country
2
Brief Summary
This research will evaluate the impact of interventions to improve pain relief and recovery following office based surgery. There will be three phases to this research. The first phase will focus on predicting recovery from office based vein surgery using a multiple regression analysis. Phase two will incorporate a randomised controlled trial to compare the effectiveness of a range of interventions in anxiety and pain reduction and recovery for office based vein surgery patients. The final phase of the investigation will utilise qualitative methodology to explore patients' experiences of each intervention and their opinions about what was and was not effective.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2012
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2011
CompletedFirst Posted
Study publicly available on registry
January 12, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedMay 21, 2014
May 1, 2014
1.5 years
December 8, 2011
May 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Level of pain experienced at the time of surgery
Measured by the McGill Pain Questionnaire
Immediately after surgery, in the recovery area participants will complete a brief measure of pain (The McGill Pain Questionnaire) up to day 1
Change in pain experienced from time of surgery to 8 weeks after surgery
Measured by the McGill Pain Questionnaire
8 weeks after date of surgery
Secondary Outcomes (2)
Recovery
8 weeks
Anxiety
Immediatley after surgery
Study Arms (5)
Control
NO INTERVENTIONparticipants will receive standard usual care
Interaction
EXPERIMENTALParticipants will interact with nurses during their procedure
Music
EXPERIMENTALParticipants will listen to music using head phones during their procedure.
Touch - stress balls
EXPERIMENTALParticipants will be provided with stress balls to use during their procedure
DVD
EXPERIMENTALParticipants will watch a DVD during their procedure and will listen to the accompanying audio through head phones
Interventions
Participants in this condition will interact with nurses during their surgery. The nurses will not touch the patient's hand during treatment as this intervention looks at interaction with another person, in the absence of tactile stimuli.
Participants will be offered a choice of music to listen to from a selection at the clinic, they will also have the opportunity of bringing or selecting their own music which can be streamed from the internet. They will listen to the music through headphones
Participants will be provided with two stress balls which they will be encouraged to squeeze during their surgery and administration of the local anaesthetic
participants will be given a choice of DVDs to watch during their procedure. A wall mounted screen will be positioned so that participants can comfortably view the screen during their procedure. they will listen to the accompanying audio through wireless headphones.
Eligibility Criteria
You may qualify if:
- To be aged over 18,
- To have given informed consent,
- To have a good understanding of written and spoken english,
- To be receiving EVLA or phlebectomies for varicose veins
You may not qualify if:
- If participants do not wish to take part due to randomisation or intervention procedures
- If they have a poor understanding of written and spoken english,
- If they are younger than 18 years of age, or older than 80
- The presence of leg ulcers
- If they are having foam treatments for thread veins
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
The Whiteley Clinic
Guildford, GU2 7RF, United Kingdom
The University of Surrey
Guildford, GU2 7XH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Briony Hudson
University of Surrey
- STUDY CHAIR
Jane Ogden
University of Surrey
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2011
First Posted
January 12, 2012
Study Start
April 1, 2012
Primary Completion
October 1, 2013
Study Completion
November 1, 2013
Last Updated
May 21, 2014
Record last verified: 2014-05