The Effects of Intra Operative Hand Reflexology for Patients Receiving Out Patient Vein Surgery
Evaluating The Effects Of Intra Operative Hand Reflexology on Pain and Anxiety During Out Patient Vein Surgery
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pain
Started Jan 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2012
CompletedFirst Posted
Study publicly available on registry
August 13, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedMay 19, 2014
May 1, 2014
1 year
August 6, 2012
May 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Anxiety
In the recovery area, immediately after surgery
Satisfaction with treatment
in the recovery area, immediately after surgery
Study Arms (2)
Hand Reflexology
EXPERIMENTALParticipants 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.
Control
NO INTERVENTIONParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- To be aged under 18 or over 80
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Whiteley Clinic at the Wimpole Clinic
London, London, W1U 4DJ, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Whiteley
The Whiteley Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2012
First Posted
August 13, 2012
Study Start
January 1, 2013
Primary Completion
January 1, 2014
Study Completion
February 1, 2014
Last Updated
May 19, 2014
Record last verified: 2014-05