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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Surrey
ClinicalTrials.gov Identifier:
NCT01508624
First received: December 8, 2011
Last updated: May 20, 2014
Last verified: May 2014

December 8, 2011
May 20, 2014
April 2012
October 2013   (final data collection date for primary outcome measure)
  • Level of pain experienced at the time of surgery [ 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 ] [ Designated as safety issue: No ]
    Measured by the McGill Pain Questionnaire
  • Change in pain experienced from time of surgery to 8 weeks after surgery [ Time Frame: 8 weeks after date of surgery ] [ Designated as safety issue: No ]
    Measured by the McGill Pain Questionnaire
Same as current
Complete list of historical versions of study NCT01508624 on ClinicalTrials.gov Archive Site
  • Recovery [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    return to pre surgical functioning, satisfaction with treatment, quality of life, symptom severity,
  • Anxiety [ Time Frame: Immediatley after surgery ] [ Designated as safety issue: No ]
    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.
Recovery [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
return to pre surgical functioning, satisfaction with treatment, quality of life, symptom severity,
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Varicose Veins
  • Pain
  • Other: Interaction
    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.
  • Other: Music
    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
  • Behavioral: Touch - stress balls
    Participants will be provided with two stress balls which they will be encouraged to squeeze during their surgery and administration of the local anaesthetic
  • Behavioral: DVD
    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.
  • No Intervention: Control
    participants will receive standard usual care
  • Experimental: Interaction
    Participants will interact with nurses during their procedure
    Intervention: Other: Interaction
  • Experimental: Music
    Participants will listen to music using head phones during their procedure.
    Intervention: Other: Music
  • Experimental: Touch - stress balls
    Participants will be provided with stress balls to use during their procedure
    Intervention: Behavioral: Touch - stress balls
  • Experimental: DVD
    Participants will watch a DVD during their procedure and will listen to the accompanying audio through head phones
    Intervention: Behavioral: DVD
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
404
November 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01508624
6045559US
Yes
University of Surrey
University of Surrey
Not Provided
Principal Investigator: Briony Hudson University of Surrey
Study Chair: Jane Ogden University of Surrey
University of Surrey
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP