Clinical trial NCT01508624: 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
Overall status: COMPLETED
Phase: NA
Conditions: Varicose Veins
Pain
Keywords: Randomised controlled trial
Pain
Recovery
Office based surgery
Lead sponsor: University of Surrey
Sponsor class: OTHER
First posted: 2012-01-12
Enrollment: 404
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Level of pain experienced at the time of surgery
timeFrame: Immediately after surgery, in the recovery area participants will complete a brief measure of pain (The McGill Pain Questionnaire) up to day 1
measure: Change in pain experienced from time of surgery to 8 weeks after surgery
timeFrame: 8 weeks after date of surgery
Secondary outcomes:
measure: Recovery
timeFrame: 8 weeks
measure: Anxiety
timeFrame: Immediatley after surgery
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: The Whiteley Clinic
city: Guildford
country: United Kingdom
facility: The University of Surrey
Study officials:
affiliation: University of Surrey
name: Briony Hudson
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Surrey
name: Jane Ogden
role: STUDY_CHAIR
References: