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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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ClinicalTrials.gov Identifier: NCT01508624
Recruitment Status : Completed
First Posted : January 12, 2012
Last Update Posted : May 21, 2014
Sponsor:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment
Varicose Veins Pain Other: Interaction Other: Music Behavioral: Touch - stress balls Behavioral: DVD

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 404 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of an Intervention to Increase Pain Relief, Perceived Anxiety and Recovery in Participants Receiving Office Based Surgery
Study Start Date : April 2012
Primary Completion Date : October 2013
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: Control
participants will receive standard usual care
Experimental: Interaction
Participants will interact with nurses during their procedure
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.
Experimental: Music
Participants will listen to music using head phones during their procedure.
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
Experimental: Touch - stress balls
Participants will be provided with stress balls to use during their procedure
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
Experimental: DVD
Participants will watch a DVD during their procedure and will listen to the accompanying audio through head phones
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.


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    Measured by the McGill Pain Questionnaire

  2. Change in pain experienced from time of surgery to 8 weeks after surgery [ Time Frame: 8 weeks after date of surgery ]
    Measured by the McGill Pain Questionnaire


Secondary Outcome Measures :
  1. Recovery [ Time Frame: 8 weeks ]
    return to pre surgical functioning, satisfaction with treatment, quality of life, symptom severity,

  2. Anxiety [ Time Frame: Immediatley after surgery ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01508624


Locations
United Kingdom
The Whiteley Clinic
Guildford, United Kingdom, GU2 7RF
The University of Surrey
Guildford, United Kingdom, GU2 7XH
Sponsors and Collaborators
University of Surrey
Investigators
Principal Investigator: Briony Hudson University of Surrey
Study Chair: Jane Ogden University of Surrey
More Information

Responsible Party: University of Surrey
ClinicalTrials.gov Identifier: NCT01508624     History of Changes
Other Study ID Numbers: 6045559US
First Posted: January 12, 2012    Key Record Dates
Last Update Posted: May 21, 2014
Last Verified: May 2014

Keywords provided by University of Surrey:
Randomised controlled trial
Pain
Recovery
Office based surgery

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases