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

Primary Purpose

Pain, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Hand Reflexology
Sponsored by
The Whiteley Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain focused on measuring Randomised controlled trial, Pain, Anxiety, Ambulatory surgery, Hand massage, Local anaesthetic

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Whiteley Clinic at the Wimpole Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hand Reflexology

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain
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
Participants will complete a numeric rating scale(0, no anxiety to 10, extreme anxiety)to assess any anxiety they experienced during treatment.
Satisfaction with treatment
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).

Full Information

First Posted
August 6, 2012
Last Updated
May 16, 2014
Sponsor
The Whiteley Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01663025
Brief Title
The Effects of Intra Operative Hand Reflexology for Patients Receiving Out Patient Vein Surgery
Official Title
Evaluating The Effects Of Intra Operative Hand Reflexology on Pain and Anxiety During Out Patient Vein Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Whiteley Clinic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anxiety
Keywords
Randomised controlled trial, Pain, Anxiety, Ambulatory surgery, Hand massage, Local anaesthetic

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hand Reflexology
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Hand Reflexology
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain
Description
Participants will complete a numeric rating scale (0 no pain - 10, extreme pain) to assess any painful sensations experienced during treatment
Time Frame
In the recovery area, immediately after surgery
Secondary Outcome Measure Information:
Title
Anxiety
Description
Participants will complete a numeric rating scale(0, no anxiety to 10, extreme anxiety)to assess any anxiety they experienced during treatment.
Time Frame
In the recovery area, immediately after surgery
Title
Satisfaction with treatment
Description
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).
Time Frame
in the recovery area, immediately after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Whiteley
Organizational Affiliation
The Whiteley Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Whiteley Clinic at the Wimpole Clinic
City
London
ZIP/Postal Code
W1U 4DJ
Country
United Kingdom

12. IPD Sharing Statement

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

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