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Completed

NCT Number: NCT01663025

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Whiteley Clinic at the Wimpole Clinic

London, W1U 4DJ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hand Reflexology

Behavioral

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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

The Whiteley Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 13, 2012
Registry last updated
May 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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