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Evaluation of Interventions to Improve Pain Relief, Perceived Anxiety and Recovery in Participants Receiving Office Based Surgery

Primary Purpose

Varicose Veins, Pain

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Interaction
Music
Touch - stress balls
DVD
Sponsored by
University of Surrey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Varicose Veins focused on measuring Randomised controlled trial, Pain, Recovery, Office based surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants will need to meet the following inclusion criteria to take part in this research:

    • 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

Exclusion Criteria:

  • The following exclusion criteria will be applied:

    • 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

Sites / Locations

  • The Whiteley Clinic
  • The University of Surrey

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Arm Label

Control

Interaction

Music

Touch - stress balls

DVD

Arm Description

participants will receive standard usual care

Participants will interact with nurses during their procedure

Participants will listen to music using head phones during their procedure.

Participants will be provided with stress balls to use during their procedure

Participants will watch a DVD during their procedure and will listen to the accompanying audio through head phones

Outcomes

Primary Outcome Measures

Level of pain experienced at the time of surgery
Measured by the McGill Pain Questionnaire
Change in pain experienced from time of surgery to 8 weeks after surgery
Measured by the McGill Pain Questionnaire

Secondary Outcome Measures

Recovery
return to pre surgical functioning, satisfaction with treatment, quality of life, symptom severity,
Anxiety
Participants will complete the state scale of the State Trait Anxiety Inventory in the waiting area immediately after surgery to indicate how anxious they felt during their procedure.

Full Information

First Posted
December 8, 2011
Last Updated
May 20, 2014
Sponsor
University of Surrey
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1. Study Identification

Unique Protocol Identification Number
NCT01508624
Brief Title
Evaluation of Interventions to Improve Pain Relief, Perceived Anxiety and Recovery in Participants Receiving Office Based Surgery
Official Title
Evaluation of an Intervention to Increase Pain Relief, Perceived Anxiety and Recovery in Participants Receiving Office Based Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Surrey

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
In recent years there has been a large increase in the amount of surgical procedures now available on an outpatient basis (Gilmartin & Wright, 2008). This is due largely to advances in surgical methods and also in response to increasing demands on the National Health Service (M. Mitchell, 2010). This shift impacts patients and health care professionals alike who must adapt to home based recovery and symptom management (Stomberg, Segerdahl, Rawal, Jakobsson, & Brattwall, 2008). This research will investigate patient's expectations, experiences, recovery and satisfaction with office based surgery conducted in a private clinic. The advancement of office based surgery has led to a rise in the number of procedures completed under local rather than general anaesthetic (Chukmaitov, Devers, Harless, Menachemi, & Brooks, 2011). Resultantly, the number of patients who are conscious during surgery has risen. The environment of the operating theatre must now be considered and nurses are become increasingly responsible for patient's mental wellbeing during surgery. For some, the prospect of being conscious during surgery can be stressful and a number of individual factors have been identified as potentially anxiety provoking (Mitchell, 2009). These range from waiting in the clinic before the surgery (Mitchell, 2008) hearing sounds of instruments being unpacked (Hankela & Kiikkala, 1996) to fears over anaesthesia (Bondy, Sims, Schroeder, Offord, & Narr). Patients' anxiety levels have been found to be high in the pre operative period (Kagan & Bar-Tal, 2008) and the links between high pre operative anxiety and poorer surgical outcomes have been well documented (Dodds 1993,Munafò & Stevenson, 2001). With this in mind, methods of reducing patient anxiety have been explored. Adapting the operating environment to better suit the needs of the patient has been found to be effective in anxiety reduction (Mark Mitchell, 2008). A powerful yet simple factor in anxiety reduction is the behaviour of the nursing staff in the operating theatre. When nurses use comforting words or touch, anxiety reductions have been observed during and before surgery (Cox & Hayes, 1997.) There is also some evidence to suggest that therapeutic touch can reduce surgical pain(Ramnarine-Singh, 1999). Other easily achievable adaptations to the operating environment that have been shown to have great anti anxiolytic effects include music (Cooke, Chaboyer, & Hiratos, 2005), audio- visual stimuli (Drahota et al., 2008), virtual reality (Hoffman et al, 2001) and massage (Kim, Cho, Woo, & Kim, 2001). The research above outlines how the addition of fairly minor interventions can be effective in improving patient's experience of office based surgery. As the growth of day surgery continues, identifying and implementing the most effective interventions for anxiety and pain reduction grows ever more important. In light of the research outlined above, this investigation will utilise a three phase approach t evaluate interventions aimed at improving pain relief and recovery following office based surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins, Pain
Keywords
Randomised controlled trial, Pain, Recovery, Office based surgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
404 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
participants will receive standard usual care
Arm Title
Interaction
Arm Type
Experimental
Arm Description
Participants will interact with nurses during their procedure
Arm Title
Music
Arm Type
Experimental
Arm Description
Participants will listen to music using head phones during their procedure.
Arm Title
Touch - stress balls
Arm Type
Experimental
Arm Description
Participants will be provided with stress balls to use during their procedure
Arm Title
DVD
Arm Type
Experimental
Arm Description
Participants will watch a DVD during their procedure and will listen to the accompanying audio through head phones
Intervention Type
Other
Intervention Name(s)
Interaction
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Music
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Touch - stress balls
Intervention Description
Participants will be provided with two stress balls which they will be encouraged to squeeze during their surgery and administration of the local anaesthetic
Intervention Type
Behavioral
Intervention Name(s)
DVD
Intervention Description
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.
Primary Outcome Measure Information:
Title
Level of pain experienced at the time of surgery
Description
Measured by the McGill Pain Questionnaire
Time Frame
Immediately after surgery, in the recovery area participants will complete a brief measure of pain (The McGill Pain Questionnaire) up to day 1
Title
Change in pain experienced from time of surgery to 8 weeks after surgery
Description
Measured by the McGill Pain Questionnaire
Time Frame
8 weeks after date of surgery
Secondary Outcome Measure Information:
Title
Recovery
Description
return to pre surgical functioning, satisfaction with treatment, quality of life, symptom severity,
Time Frame
8 weeks
Title
Anxiety
Description
Participants will complete the state scale of the State Trait Anxiety Inventory in the waiting area immediately after surgery to indicate how anxious they felt during their procedure.
Time Frame
Immediatley after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants will need to meet the following inclusion criteria to take part in this research: 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 Exclusion Criteria: The following exclusion criteria will be applied: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Briony Hudson
Organizational Affiliation
University of Surrey
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jane Ogden
Organizational Affiliation
University of Surrey
Official's Role
Study Chair
Facility Information:
Facility Name
The Whiteley Clinic
City
Guildford
ZIP/Postal Code
GU2 7RF
Country
United Kingdom
Facility Name
The University of Surrey
City
Guildford
ZIP/Postal Code
GU2 7XH
Country
United Kingdom

12. IPD Sharing Statement

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Evaluation of Interventions to Improve Pain Relief, Perceived Anxiety and Recovery in Participants Receiving Office Based Surgery

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