Mental StressNCT02955914
The Effect of Patient Optimism & Pessimism on Recovery From Elective Cardiac Surgery
An observational study of Mental Stress, run by Dr Vikki Hughes at 1 site in United Kingdom.
Trial summary
Before a heart operation, patient outlook may be either pessimistic or optimistic. Previous research on this topic has focused on patient reported quality of life but has never examined measurable clinical outcomes such as length of hospital stay.This pilot study hopes to establish whether patient outlook (optimistic… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Mental Stress
- How many people
- 419 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2016to Dec 2017
- Phase
- Observational
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients will be elective cardiac surgical patients undergoing major cardiac surgery.
Who may be able to join
- Age over 18
- Elective planned cardiac surgery
- Consent to participate
Who cannot join
- Patients diagnosed with clinical depression
- Patients deemed not competent to provide consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Papworth Hospital NHS Foundation Trust
Cambridge, CB23 3RE
Christine Mills, 01480 830541 ext. 4144, christine.mills@nhs.net
Sarah Evans, 01480 830541 ext. 4614, sarah.evans@nhs.net
About this study
Before a heart operation, patient outlook may be either pessimistic or optimistic. Previous research on this topic has focused on patient reported quality of life but has never examined measurable clinical outcomes such as length of hospital stay.This pilot study hopes to establish whether patient outlook (optimistic or pessimistic) before a heart operation can influence recovery and length of hospital stay. If there is a difference, then a case can be made for providing psychological support before an operation in the hope of modifying outlook and thus improving patient care and reducing hospital stay and NHS costs. Patients will be recruited over a 12month period. Their outlook (pessimistic or optimistic) will be ascertained using two standardised questionnaires. Their recovery and length of stay will be recorded. The study will answer the research question and determine whether outlook has an impact on recovery. Depending on the results, this study could provide opportunities for additional future research into modifying outlook with a view to improving patient care and recovery.
- Conditions
- Mental Stress
- Keywords
- Optimism, Pessimism, Recovery, Elective Cardiac surgery
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Optimism | Based on quality of life assessment | |
| Pessimism | Based on quality of life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Measured: Discharge from hospital (average of 10 days)
Secondary outcomes (2)
Length of ITU stay
Measured: 2 days
Risk-adjusted survival
Measured: Discharge from hospital (average of 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study startSep 2016
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental StressStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 419 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Vikki Hughes
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Dr Vikki Hughes, Papworth Hospital NHS Foundation Trust
- Investigators
- Christine Mills, Principal investigator, Papworth Hospital NHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02955914
- Sponsor's protocol ID
- P02022
- Status last verified
- May 2017
- First submitted
- 15 Sep 2016
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The data will be disseminated among the research team. Patients can see a copy of the final report upon request.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Patient Optimism & Pessimism on Recovery From Elective Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02955914
- Acronym / sponsor ID
- P02022
- Conditions
- Mental Stress
- Keywords
- Optimism, Pessimism, Recovery, Elective Cardiac surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 419 participants (estimated)
- Lead sponsor
- Dr Vikki HughesOther government
- Study start
- Sep 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 4 Nov 2016 (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.
Before a heart operation, patient outlook may be either pessimistic or optimistic. Previous research on this topic has focused on patient reported quality of life but has never examined measurable clinical outcomes such as length of hospital stay.This pilot study hopes to establish whether patient outlook (optimistic or pessimistic) before a heart operation can influence recovery and length of hospital stay. If there is a difference, then a case can be made for providing psychological support before an operation in the hope of modifying outlook and thus improving patient care and reducing hospital stay and NHS costs. Patients will be recruited over a 12month period. Their outlook (pessimistic or optimistic) will be ascertained using two standardised questionnaires. Their recovery and length of stay will be recorded. The study will answer the research question and determine whether outlook has an impact on recovery. Depending on the results, this study could provide opportunities for additional future research into modifying outlook with a view to improving patient care and recovery.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimism | – | –Based on quality of life assessment |
| Pessimism | – | –Based on quality of life assessment |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients will be elective cardiac surgical patients undergoing major cardiac surgery.
Key inclusion criteria (3 listed)
- Age over 18
- Elective planned cardiac surgery
- Consent to participate
Key exclusion criteria (2 listed)
- Patients diagnosed with clinical depression
- Patients deemed not competent to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Length of hospital stay
Time frame: Discharge from hospital (average of 10 days)
2 secondary outcomes
Length of ITU stay
Time frame: 2 days
Risk-adjusted survival
Time frame: Discharge from hospital (average of 10 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Individual participant dataSharing planned: Yes. The data will be disseminated among the research team. Patients can see a copy of the final report upon request.
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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.
Christine Mills principal investigator
Papworth Hospital NHS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Stress, run by Dr Vikki Hughes at 1 site 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Evans (01480 364614 ext. 4614, sarah.evans@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: Discharge from hospital (average of 10 days)). 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 5 May 2017.