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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01663025
Recruitment Status : Completed
First Posted : August 13, 2012
Last Update Posted : May 19, 2014
Information provided by (Responsible Party):
The Whiteley Clinic

Brief Summary:
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 or disease Intervention/treatment Phase
Pain Anxiety Behavioral: Hand Reflexology Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arm Intervention/treatment
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.

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

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

  2. Satisfaction with treatment [ Time Frame: in the recovery area, immediately after surgery ]
    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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01663025

United Kingdom
The Whiteley Clinic at the Wimpole Clinic
London, United Kingdom, W1U 4DJ
Sponsors and Collaborators
The Whiteley Clinic
Principal Investigator: Mark Whiteley The Whiteley Clinic

Responsible Party: The Whiteley Clinic Identifier: NCT01663025     History of Changes
Other Study ID Numbers: WC1HM
First Posted: August 13, 2012    Key Record Dates
Last Update Posted: May 19, 2014
Last Verified: May 2014

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

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders