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

Not Applicable

Completed

• Conditions: Varicose Veins; Pain
• Interventions: Other: Interaction; Other: Music; Behavioral: Touch - stress balls; Behavioral: DVD

• Registration Number: NCT01508624
• Lead Sponsor: University of Surrey

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.

Study Timeline

• Study First Submitted: 2011-12-08
• Study First Submitted QC: 2012-01-09
• Study First Posted: 2012-01-12
• Study Start: 2012-04
• Primary Completion: 2013-10
• Study Completion: 2013-11
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-20
• Last Update Posted: 2014-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 404

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interaction	Interaction	Participants will interact with nurses during their procedure
Music	Music	Participants will listen to music using head phones during their procedure.
Touch - stress balls	Touch - stress balls	Participants will be provided with stress balls to use during their procedure
DVD	DVD	Participants will watch a DVD during their procedure and will listen to the accompanying audio through head phones

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Recovery	8 weeks	return to pre surgical functioning, satisfaction with treatment, quality of life, symptom severity,
Anxiety	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.

Trial Locations

Locations (2)

The Whiteley Clinic; 🇬🇧 Guildford, United Kingdom

The University of Surrey; 🇬🇧 Guildford, United Kingdom