CClinicalTrials.gg
CompletedNCT01508624Updated May 21, 2014

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

An interventional study of Interaction and Music in Varicose Veins and Pain, sponsored by University of Surrey. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-05-21.

Sponsored by University of Surrey · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
404
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Varicose Veins
  • Pain

Browse trials for

Keywords

  • Randomised controlled trial
  • Pain
  • Recovery
  • Office based surgery
03

In context

Varicose Veins

253 studies on the registry are indexed under Varicose Veins; 35 are open to participants now.

This study's enrollment of 404 is above the median of 104 across 162 interventional studies indexed under Varicose Veins.

Browse Varicose Veins studies →

Lead sponsor

University of Surrey is the lead sponsor of 90 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
404 participants (actual)

Study arms

  • No intervention
    Control

    participants will receive standard usual care

  • Experimental
    Interaction

    Participants will interact with nurses during their procedure

    Other: Interaction

  • Experimental
    Music

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

    Other: Music

  • Experimental
    Touch - stress balls

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

    Behavioral: Touch - stress balls

  • Experimental
    DVD

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

    Behavioral: DVD

Interventions

  • OtherInteraction

    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.

  • OtherMusic

    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

  • BehavioralTouch - 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

  • BehavioralDVD

    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.

06

What researchers measure

Primary outcomes

  1. Level of pain experienced at the time of surgery

    Measured by the McGill Pain Questionnaire

    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

  2. Change in pain experienced from time of surgery to 8 weeks after surgery

    Measured by the McGill Pain Questionnaire

    Time frame: 8 weeks after date of surgery

Secondary outcomes

  1. Recovery

    return to pre surgical functioning, satisfaction with treatment, quality of life, symptom severity,

    Time frame: 8 weeks

  2. Anxiety

    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.

    Time frame: Immediatley after surgery

07

Study locations

2 sites
  • The Whiteley Clinic
    Guildford, GU2 7RF, United Kingdom
  • The University of Surrey
    Guildford, GU2 7XH, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01508624
Lead sponsor
University of Surrey
Responsible party
Sponsor
First posted
Jan 12, 2012
Start date
Apr 2012
Primary completion
Oct 2013
Completion
Nov 2013
Last update
May 21, 2014

Study contacts

Briony Hudson
principal investigator · University of Surrey
Jane Ogden
study chair · University of Surrey

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion