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

Not Applicable

Completed

• Conditions: Pain; Anxiety
• Interventions: Behavioral: Hand Reflexology

• Registration Number: NCT01663025
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2012-08-06
• Study First Submitted QC: 2012-08-08
• Study First Posted: 2012-08-13
• Study Start: 2013-01
• Primary Completion: 2014-01
• Study Completion: 2014-02
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-16
• Last Update Posted: 2014-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hand Reflexology	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.

Primary Outcome Measures

Name	Time	Method
Pain	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

Name	Time	Method
Anxiety	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.
Satisfaction with treatment	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).

Trial Locations

Locations (1)

The Whiteley Clinic at the Wimpole Clinic; 🇬🇧 London, United Kingdom