The Effects of Intra Operative Hand Reflexology for Patients Receiving Out Patient Vein Surgery

This study is currently recruiting participants.
Verified August 2013 by The Whiteley Clinic
Sponsor:
Information provided by (Responsible Party):
The Whiteley Clinic
ClinicalTrials.gov Identifier:
NCT01663025
First received: August 6, 2012
Last updated: August 16, 2013
Last verified: August 2013
  Purpose

This randomised controlled trial aims to compare the effectiveness of hand reflexology received during office based vein surgery, under local anaesthetic on patient's reports of pain and anxiety, compared to usual standard care.


Condition Intervention
Pain
Anxiety
Behavioral: Hand Reflexology

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Evaluating The Effects Of Intra Operative Hand Reflexology on Pain and Anxiety During Out Patient Vein Surgery

Resource links provided by NLM:


Further study details as provided by The Whiteley Clinic:

Primary Outcome Measures:
  • Pain [ Time Frame: In the recovery area, immediately after surgery ] [ Designated as safety issue: No ]
    Participants will complete a numeric rating scale (0 no pain - 10, extreme pain) to assess any painful sensations experienced during treatment


Secondary Outcome Measures:
  • Anxiety [ Time Frame: In the recovery area, immediately after surgery ] [ Designated as safety issue: No ]
    Participants will complete a numeric rating scale(0, no anxiety to 10, extreme anxiety)to assess any anxiety they experienced during treatment.

  • Time taken to return to normal functioning following surgery [ Time Frame: 8 weeks after surgery, when the participant attends the clinic for a follow up appointment ] [ Designated as safety issue: No ]
    Participants will be asked to indicate how long (in days) it took them to return to their normal levels of functioning after their surgery

  • Ratings of pain experienced in the first 4 weeks after surgery [ Time Frame: 8 weeks after surgery, when participants return to the clinic for their follow up appointment ] [ Designated as safety issue: No ]
    Participants will be asked to rate the pain that they experienced over the first 4 weeks after their surgery.

  • Symptom severity [ Time Frame: 8 weeks after surgery, when participants return to the clinic for their follow up appointment ] [ Designated as safety issue: No ]
    Participants will be asked to rate the severity of any remaining symptoms experienced from their veins following surgery.

  • Satisfaction with treatment [ Time Frame: 8 weeks after surgery, when participants return to the clinic for their follow up appointment ] [ Designated as safety issue: No ]
    Participants will be asked to rate how satisfied they are with the treatment that they have received on a scale of 1 (very dissatisfied) to 5 (very satisfied).


Estimated Enrollment: 200
Study Start Date: January 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hand Reflexology
Participants in this condition will receive hand reflexology, performed by a trained reflexologist during their treatment. This will be in addition to usual standard care therefore the surgeon will speak to the participant occasionally to ensure they are comfortable.
Behavioral: Hand Reflexology
The hand reflexology will begin in theatre, before the local anaesthetic is administered and will continue until the patient is ready to leave the operating theatre.
No Intervention: Control
Participants in condition will form the control group for the study. They will receive usual standard care during treatment which will involve the surgeon speaking to them occasionally to ensure that they are comfortable.

Detailed Description:

The negative effects of anxiety and pain on surgical recovery are well documented. It is also accepted that distraction can be effective in pain reduction. This randomised controlled trial will explore the effect of intra operative hand reflexology on pain perception and anxiety during office-based surgery under local anaesthetic. Participants will be randomly allocated to either the experimental condition, in which they will receive a hand reflexology during treatment, or control condition in which they will receive usual standard care. Immediate and longer term outcomes will be explored.

Eight weeks after surgery, participants will return to the clinic for a follow up appointment. While they are in the waiting area they will be asked to complete a short questionnaire to assess time taken to return to pre surgical levels of functioning, pain experienced in the first four weeks after surgery, severity of venous symptoms and satisfaction with treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • To be aged between 18 and 80
  • To be able to give informed consent
  • To be receiving, endovenous laser ablation or phlebectomies for the treatment of varicose veins
  • To have a good understanding of written and spoken English.
  • To arrive at the clinic with sufficient time before their procedure to give consent and complete the questionnaire (>20 mins)

Exclusion Criteria:

-To be aged under 18 or over 80

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01663025

Contacts
Contact: Briony Hudson 01483 477180 b.f.hudson@surrey.ac.uk
Contact: Mark Whiteley 01483 477180 mark@thewhiteleyclinic.co.uk

Locations
United Kingdom
The Whiteley Clinic at the Wimpole Clinic Recruiting
London, United Kingdom, W1U 4DJ
Contact: Mark Whitley       mark@thewhiteleyclinic.co.uk   
Contact: Briony Hudson       b.f.hudson@surrey.ac.uk   
Principal Investigator: Mark Whiteley         
Sponsors and Collaborators
The Whiteley Clinic
Investigators
Principal Investigator: Mark Whiteley The Whiteley Clinic
  More Information

No publications provided

Responsible Party: The Whiteley Clinic
ClinicalTrials.gov Identifier: NCT01663025     History of Changes
Other Study ID Numbers: WC1HM
Study First Received: August 6, 2012
Last Updated: August 16, 2013
Health Authority: United Kingdom: National Health Service

Keywords provided by The Whiteley Clinic:
Randomised controlled trial
Pain
Anxiety
Ambulatory surgery
Hand massage
Local anaesthetic

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 20, 2014