Completed

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

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What is being tested

Hand Reflexology

Behavioral
Who is being recruted

Mental Disorders+3

+ Neurologic Manifestations

+ Signs and Symptoms

From 18 to 80 Years
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: January 2013
See protocol details

Summary

Principal SponsorThe Whiteley Clinic
Last updated: May 19, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01663025
Principal SponsorThe Whiteley Clinic
Last updated: May 19, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAnxiety DisordersPain

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Group II

No Intervention
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

The Whiteley Clinic at the Wimpole Clinic

London, United KingdomOpen The Whiteley Clinic at the Wimpole Clinic in Google Maps
CompletedOne Study Center