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

Pain Clinical Trial

Official title:

Evaluating The Effects Of Intra Operative Hand Reflexology on Pain and Anxiety During Out Patient Vein Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01663025
• Other study ID #: WC1HM
• Status: Completed
• Phase: N/A
• First received: August 6, 2012
• Last updated: May 16, 2014
• Start date: January 2013
• Est. completion date: February 2014

Study information

• Verified date: May 2014
• Source: The Whiteley Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anxiety
• Pain

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	The Whiteley Clinic at the Wimpole Clinic	London

Sponsors (1)

Lead Sponsor	Collaborator
The Whiteley Clinic

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Participants will complete a numeric rating scale (0 no pain - 10, extreme pain) to assess any painful sensations experienced during treatment	In the recovery area, immediately after surgery	No
Secondary	Anxiety	Participants will complete a numeric rating scale(0, no anxiety to 10, extreme anxiety)to assess any anxiety they experienced during treatment.	In the recovery area, immediately after surgery	No
Secondary	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).	in the recovery area, immediately after surgery	No