Varicose VeinsNCT01508624
Evaluation of Interventions to Improve Pain Relief, Perceived Anxiety and Recovery in Participants Receiving Office Based Surgery
A study testing Interaction, Music and Touch - stress balls in people with Varicose Veins and Pain, run by University of Surrey at 2 sites in United Kingdom.
Trial summary
This research will evaluate the impact of interventions to improve pain relief and recovery following office based surgery. There will be three phases to this research. The first phase will focus on predicting recovery from office based vein surgery using a multiple regression analysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins, Pain
- What is being tested?
- Interaction, Music and Touch - stress balls
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Apr 2012to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will need to meet the following inclusion criteria to take part in this research:
- To be aged over 18,
- To have given informed consent,
- To have a good understanding of written and spoken english,
- To be receiving EVLA or phlebectomies for varicose veins
Who cannot join
- The following exclusion criteria will be applied:
- If participants do not wish to take part due to randomisation or intervention procedures
- If they have a poor understanding of written and spoken english,
- If they are younger than 18 years of age, or older than 80
- The presence of leg ulcers
- If they are having foam treatments for thread veins
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
The Whiteley Clinic
Guildford, GU2 7RF
The University of Surrey
Guildford, GU2 7XH
About this study
Official title: Evaluation of an Intervention to Increase Pain Relief, Perceived Anxiety and Recovery in Participants Receiving Office Based Surgery
This research will evaluate the impact of interventions to improve pain relief and recovery following office based surgery.
There will be three phases to this research. The first phase will focus on predicting recovery from office based vein surgery using a multiple regression analysis.
Phase two will incorporate a randomised controlled trial to compare the effectiveness of a range of interventions in anxiety and pain reduction and recovery for office based vein surgery patients.
The final phase of the investigation will utilise qualitative methodology to explore patients' experiences of each intervention and their opinions about what was and was not effective.
Read the detailed description
In recent years there has been a large increase in the amount of surgical procedures now available on an outpatient basis (Gilmartin \& Wright, 2008). This is due largely to advances in surgical methods and also in response to increasing demands on the National Health Service (M. Mitchell, 2010). This shift impacts patients and health care professionals alike who must adapt to home based recovery and symptom management (Stomberg, Segerdahl, Rawal, Jakobsson, \& Brattwall, 2008). This research will investigate patient's expectations, experiences, recovery and satisfaction with office based surgery conducted in a private clinic.
The advancement of office based surgery has led to a rise in the number of procedures completed under local rather than general anaesthetic (Chukmaitov, Devers, Harless, Menachemi, \& Brooks, 2011). Resultantly, the number of patients who are conscious during surgery has risen. The environment of the operating theatre must now be considered and nurses are become increasingly responsible for patient's mental wellbeing during surgery. For some, the prospect of being conscious during surgery can be stressful and a number of individual factors have been identified as potentially anxiety provoking (Mitchell, 2009). These range from waiting in the clinic before the surgery (Mitchell, 2008) hearing sounds of instruments being unpacked (Hankela \& Kiikkala, 1996) to fears over anaesthesia (Bondy, Sims, Schroeder, Offord, \& Narr). Patients' anxiety levels have been found to be high in the pre operative period (Kagan \& Bar-Tal, 2008) and the links between high pre operative anxiety and poorer surgical outcomes have been well documented (Dodds 1993,Munafò \& Stevenson, 2001).
With this in mind, methods of reducing patient anxiety have been explored. Adapting the operating environment to better suit the needs of the patient has been found to be effective in anxiety reduction (Mark Mitchell, 2008). A powerful yet simple factor in anxiety reduction is the behaviour of the nursing staff in the operating theatre. When nurses use comforting words or touch, anxiety reductions have been observed during and before surgery (Cox \& Hayes, 1997.) There is also some evidence to suggest that therapeutic touch can reduce surgical pain(Ramnarine-Singh, 1999). Other easily achievable adaptations to the operating environment that have been shown to have great anti anxiolytic effects include music (Cooke, Chaboyer, \& Hiratos, 2005), audio- visual stimuli (Drahota et al., 2008), virtual reality (Hoffman et al, 2001) and massage (Kim, Cho, Woo, \& Kim, 2001).
The research above outlines how the addition of fairly minor interventions can be effective in improving patient's experience of office based surgery. As the growth of day surgery continues, identifying and implementing the most effective interventions for anxiety and pain reduction grows ever more important.
In light of the research outlined above, this investigation will utilise a three phase approach t evaluate interventions aimed at improving pain relief and recovery following office based surgery.
- Conditions
- Varicose Veins, Pain
- Being tested
- Interaction, Music, Touch - stress balls, DVD
- Keywords
- Randomised controlled trial, Pain, Recovery, Office based surgery
- Medical subject headings
- Varicose Veins, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InteractionOther
Participants in this condition will interact with nurses during their surgery. The nurses will not touch the patient's hand during treatment as this intervention looks at interaction with another person, in the absence of tactile stimuli.
MusicOther
Participants will be offered a choice of music to listen to from a selection at the clinic, they will also have the opportunity of bringing or selecting their own music which can be streamed from the internet. They will listen to the music through headphones
Touch - stress ballsBehavioural
Participants will be provided with two stress balls which they will be encouraged to squeeze during their surgery and administration of the local anaesthetic
DVDBehavioural
participants will be given a choice of DVDs to watch during their procedure. A wall mounted screen will be positioned so that participants can comfortably view the screen during their procedure. they will listen to the accompanying audio through wireless headphones.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | participants will receive standard usual care |
| Interaction | Experimental | Participants will interact with nurses during their procedure Receives: Other: Interaction |
| Music | Experimental | Participants will listen to music using head phones during their procedure. Receives: Other: Music |
| Touch - stress balls | Experimental | Participants will be provided with stress balls to use during their procedure Receives: Behavioral: Touch - stress balls |
| DVD | Experimental | Participants will watch a DVD during their procedure and will listen to the accompanying audio through head phones Receives: Behavioral: DVD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of pain experienced at the time of surgery
Measured by the McGill Pain Questionnaire
Measured: Immediately after surgery, in the recovery area participants will complete a brief measure of pain (The McGill Pain Questionnaire) up to day 1
Change in pain experienced from time of surgery to 8 weeks after surgery
Measured by the McGill Pain Questionnaire
Measured: 8 weeks after date of surgery
Secondary outcomes (2)
Recovery
return to pre surgical functioning, satisfaction with treatment, quality of life, symptom severity,
Measured: 8 weeks
Anxiety
Participants will complete the state scale of the State Trait Anxiety Inventory in the waiting area immediately after surgery to indicate how anxious they felt during their procedure.
Measured: Immediatley after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Briony Hudson, Principal investigator, University of SurreyJane Ogden, Study chair, University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508624
- Sponsor's protocol ID
- 6045559US
- Status last verified
- May 2014
- First submitted
- 8 Dec 2011
- Last updated
- 21 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Intervention to Increase Pain Relief, Perceived Anxiety and Recovery in Participants Receiving Office Based Surgery
- ClinicalTrials.gov ID
- NCT01508624
- Acronym / sponsor ID
- 6045559US
- Conditions
- Varicose Veins, Pain
- Keywords
- Randomised controlled trial, Pain, Recovery, Office based surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 12 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research will evaluate the impact of interventions to improve pain relief and recovery following office based surgery.
There will be three phases to this research. The first phase will focus on predicting recovery from office based vein surgery using a multiple regression analysis.
Phase two will incorporate a randomised controlled trial to compare the effectiveness of a range of interventions in anxiety and pain reduction and recovery for office based vein surgery patients.
The final phase of the investigation will utilise qualitative methodology to explore patients' experiences of each intervention and their opinions about what was and was not effective.
Detailed description
In recent years there has been a large increase in the amount of surgical procedures now available on an outpatient basis (Gilmartin \& Wright, 2008). This is due largely to advances in surgical methods and also in response to increasing demands on the National Health Service (M. Mitchell, 2010). This shift impacts patients and health care professionals alike who must adapt to home based recovery and symptom management (Stomberg, Segerdahl, Rawal, Jakobsson, \& Brattwall, 2008). This research will investigate patient's expectations, experiences, recovery and satisfaction with office based surgery conducted in a private clinic.
The advancement of office based surgery has led to a rise in the number of procedures completed under local rather than general anaesthetic (Chukmaitov, Devers, Harless, Menachemi, \& Brooks, 2011). Resultantly, the number of patients who are conscious during surgery has risen. The environment of the operating theatre must now be considered and nurses are become increasingly responsible for patient's mental wellbeing during surgery. For some, the prospect of being conscious during surgery can be stressful and a number of individual factors have been identified as potentially anxiety provoking (Mitchell, 2009). These range from waiting in the clinic before the surgery (Mitchell, 2008) hearing sounds of instruments being unpacked (Hankela \& Kiikkala, 1996) to fears over anaesthesia (Bondy, Sims, Schroeder, Offord, \& Narr). Patients' anxiety levels have been found to be high in the pre operative period (Kagan \& Bar-Tal, 2008) and the links between high pre operative anxiety and poorer surgical outcomes have been well documented (Dodds 1993,Munafò \& Stevenson, 2001).
With this in mind, methods of reducing patient anxiety have been explored. Adapting the operating environment to better suit the needs of the patient has been found to be effective in anxiety reduction (Mark Mitchell, 2008). A powerful yet simple factor in anxiety reduction is the behaviour of the nursing staff in the operating theatre. When nurses use comforting words or touch, anxiety reductions have been observed during and before surgery (Cox \& Hayes, 1997.) There is also some evidence to suggest that therapeutic touch can reduce surgical pain(Ramnarine-Singh, 1999). Other easily achievable adaptations to the operating environment that have been shown to have great anti anxiolytic effects include music (Cooke, Chaboyer, \& Hiratos, 2005), audio- visual stimuli (Drahota et al., 2008), virtual reality (Hoffman et al, 2001) and massage (Kim, Cho, Woo, \& Kim, 2001).
The research above outlines how the addition of fairly minor interventions can be effective in improving patient's experience of office based surgery. As the growth of day surgery continues, identifying and implementing the most effective interventions for anxiety and pain reduction grows ever more important.
In light of the research outlined above, this investigation will utilise a three phase approach t evaluate interventions aimed at improving pain relief and recovery following office based surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –participants will receive standard usual care |
| Interaction | Experimental | Other: InteractionParticipants will interact with nurses during their procedure |
| Music | Experimental | Other: MusicParticipants will listen to music using head phones during their procedure. |
| Touch - stress balls | Experimental | Behavioral: Touch - stress ballsParticipants will be provided with stress balls to use during their procedure |
| DVD | Experimental | Behavioral: DVDParticipants will watch a DVD during their procedure and will listen to the accompanying audio through head phones |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants will need to meet the following inclusion criteria to take part in this research:
Key exclusion criteria (6 listed)
- The following exclusion criteria will be applied:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InteractionParticipants in this condition will interact with nurses during their surgery. The nurses will not touch the patient's hand during treatment as this intervention looks at interaction with another person, in the absence of tactile stimuli. | Other | Interaction |
| MusicParticipants will be offered a choice of music to listen to from a selection at the clinic, they will also have the opportunity of bringing or selecting their own music which can be streamed from the internet. They will listen to the music through headphones | Other | Music |
| Touch - stress ballsParticipants will be provided with two stress balls which they will be encouraged to squeeze during their surgery and administration of the local anaesthetic | Behavioural | Touch - stress balls |
| DVDparticipants will be given a choice of DVDs to watch during their procedure. A wall mounted screen will be positioned so that participants can comfortably view the screen during their procedure. they will listen to the accompanying audio through wireless headphones. | Behavioural | DVD |
Primary outcome
Level of pain experienced at the time of surgery
Time frame: Immediately after surgery, in the recovery area participants will complete a brief measure of pain (The McGill Pain Questionnaire) up to day 1
Measured by the McGill Pain Questionnaire
Change in pain experienced from time of surgery to 8 weeks after surgery
Time frame: 8 weeks after date of surgery
Measured by the McGill Pain Questionnaire
2 secondary outcomes
Recovery
Time frame: 8 weeks
Anxiety
Time frame: Immediatley after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Briony Hudson principal investigator
University of Surrey
Jane Ogden study chair
University of Surrey
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interaction, Music and Touch - stress balls in people with Varicose Veins and Pain, run by University of Surrey at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of pain experienced at the time of surgery (time frame: Immediately after surgery, in the recovery area participants will complete a brief measure of pain (The McGill Pain Questionnaire) up to day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2014.