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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain, Anxiety

Intervention / Treatment
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* Behavioral: Hand Reflexology


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hand Reflexology<br>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. | Behavioral: Hand Reflexology<br>* 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.<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomised controlled trial, Pain, Anxiety, Ambulatory surgery, Hand massage, Local anaesthetic