Evaluation of an Intervention to Increase Pain Relief and Recovery in Participants Receiving Office Based Surgery

This study is currently recruiting participants.
Verified January 2013 by University of Surrey
Sponsor:
Information provided by (Responsible Party):
University of Surrey
ClinicalTrials.gov Identifier:
NCT01508624
First received: December 8, 2011
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

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 and cosmetic procedures 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 Intervention
Varicose Veins
Pain
Other: Dedicated Nurse
Other: Music
Device: Transcutaneous electrical nerve stimulation
Behavioral: Massage and interaction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: Evaluation of an Intervention to Increase Pain Relief and Recovery in Participants Receiving Office Based Surgery

Resource links provided by NLM:


Further study details as provided by University of Surrey:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Recovery [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    return to pre surgical functioning, satisfaction with treatment, quality of life, symptom severity,


Estimated Enrollment: 1000
Study Start Date: April 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
participants will receive standard usual care
Experimental: Dedicated Nurse
Participants will be provided with a dedicated nurse for their entire surgical experience
Other: Dedicated Nurse
Patients in this condition will be provided with a dedicated nurse during their entire surgical experience. Starting the in the pre-operative stage, the nurse will be on hand to provide reassurance and answer questions about the procedure and anaesthetic. The nurse will accompany the patient into the operating theatre and will be positioned next to them during surgery to talk with them in an attempt to reduce anxiety. The nurse will also take the participant into the recovery room, answer any queries and discuss aftercare. They would 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 given a Walkman and headphone and a demonstration of how to operate the Walkman, allowing them to adjust volume controls during treatment. They will not be a given a choice of the type of music to listen to
Experimental: TENS machine
Participants will use a Transcutaneous electrical nerve stimulation machine during treatment
Device: Transcutaneous electrical nerve stimulation
The rational and use of the TENS machine will be explained to participants before the procedure takes place. The machine's controls will be demonstrated to allow participants to adjust settings as they wish during the procedure to reinforce a sense of control.
Experimental: Massage and interaction.
Participants will receive a massage from a dedicated nurse during treatment who will also interact with the participant verbally.
Behavioral: Massage and interaction
Participants will be assigned a dedicated nurse in this condition, as outlined in the dedicated nurse condition. In this condition, the nurse will also massage the participants hand or arm and will also be instructed to talk with the participant to put them at ease during the procedure. The participant would be able to say whether or not they wished to speak to the nurse, incorporating an element of control into the condition.

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 and anaesthetic 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 office based surgery,

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508624

Contacts
Contact: Briony Hudson 07838 750 8555 bh00047@surrey.ac.uk
Contact: Jane Ogden j.ogden@surrey.ac.uk

Locations
United Kingdom
The Whiteley Clinic Recruiting
Guildford, United Kingdom, GU2 7RF
Contact: B Hudson       briony@thewhiteleyclinic.co.uk   
Principal Investigator: Briony Hudson         
The University of Surrey Active, not recruiting
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

No publications provided

Responsible Party: University of Surrey
ClinicalTrials.gov Identifier: NCT01508624     History of Changes
Other Study ID Numbers: 6045559US
Study First Received: December 8, 2011
Last Updated: January 15, 2013
Health Authority: United Kingdom: National Health Service

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

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014