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

NCT ID: NCT01508624

Last Updated: 2014-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 404 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-11-30

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.

Conditions

Varicose Veins; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control

participants will receive standard usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interaction

Participants will interact with nurses during their procedure

Group Type: EXPERIMENTAL

Interaction

Intervention Type: OTHER

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.

Music

Participants will listen to music using head phones during their procedure.

Group Type: EXPERIMENTAL

Music

Intervention Type: OTHER

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

Touch - stress balls

Participants will be provided with stress balls to use during their procedure

Group Type: EXPERIMENTAL

Touch - stress balls

Intervention Type: BEHAVIORAL

Participants will be provided with two stress balls which they will be encouraged to squeeze during their surgery and administration of the local anaesthetic

DVD

Participants will watch a DVD during their procedure and will listen to the accompanying audio through head phones

Group Type: EXPERIMENTAL

DVD

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Surrey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Briony Hudson

Role: PRINCIPAL_INVESTIGATOR

University of Surrey

Jane Ogden

Role: STUDY_CHAIR

University of Surrey

Locations

The Whiteley Clinic

Guildford, , United Kingdom

The University of Surrey

Guildford, , United Kingdom

Countries

United Kingdom

Other Identifiers

6045559US

Identifier Type: -

Identifier Source: org_study_id