Social SupportPOPQUESTNCT05009316
Impact of Social Support and Coping Strategies on Post-Surgical Pain
A study testing Questionnaires in people with Social Support and Coping Behavior, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The purpose of the study is to evaluate the impact of social support and pain coping strategies in the development and evolution of post-surgical pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Support, Coping Behavior, Post-Surgical Pain, Chronic
- What is being tested?
- Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Sep 2021to 21 Mar 2024
- 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
- Aged over 18 years of age.
- Capacity to understand and voluntarily sign an informed consent form in French.
Who cannot join
- Insufficient French language skills.
- History of psychotic disease.
- History of neurodegenerative pathology.
- History of neurological disease (e.g. stroke)
- Pre-existing pain condition related to the reason for surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Social Support and Coping Strategies on the Development and Evolution of Post-Surgical Pain
The purpose of the study is to evaluate the impact of social support and pain coping strategies in the development and evolution of post-surgical pain.
Read the detailed description
This is a longitudinal study. After giving their informed consent, patients will answer online questionnaires assessing pain and different psychosocial variables at these time points: before surgery, one to three days after surgery, and one, three, and six months after surgery.
The psychosocial variables evaluated are the following ones :
- Depression,
- Anxiety,
- Stress,
- Pain Coping Strategies,
- Social Support,
- Couple Support.
- Conditions
- Social Support, Coping Behavior, Post-Surgical Pain, Chronic
- Being tested
- Questionnaires
- Keywords
- Pain, Chronic
- Medical subject headings
- Pain, Postoperative, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Online-based questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Questionnaires | Experimental | Patients will answer online surveys containing different questionnaires that will evaluate psychosocial variables as well as pain variables. Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of acute post-surgical pain
Questions from the Short Form of the Brief Pain Inventory (translated in French) will be used to assess the intensity of the pain on a numeric rating scale (from 0 to 10) during the three days following surgery.
Measured: Three days after surgery
Development of Persistent post-surgical pain, 3 months
Using the Short Form of the Brief Pain Inventory, pain will be assessed at three months to determine whether patients will have developed chronic pain.
Measured: 3 months after surgery
Persistent post-surgical pain, 6 months
Using the Short Form of the Brief Pain Inventory, pain intensity will be assessed at 6 months.
Measured: 6 months after surgery
Pain interference
Using the Short Form of the Brief Pain Inventory, pain interference on daily activities will be assessed at 6 months.
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start20 Sep 2021
- Primary completion20 Dec 2023
- Study completion21 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social SupportStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 368 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission
- Responsible party
- Sponsor
- Investigators
- André Mouraux, Ph.D, Study chair, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009316
- Sponsor's protocol ID
- POPQUEST
- Acronym
- POPQUEST
- Status last verified
- Apr 2024
- First submitted
- 16 Aug 2021
- Last updated
- 10 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Social Support and Coping Strategies on the Development and Evolution of Post-Surgical Pain
- ClinicalTrials.gov ID
- NCT05009316
- Acronym / sponsor ID
- POPQUEST / POPQUEST
- Conditions
- Social Support, Coping Behavior, Post-Surgical Pain, Chronic
- Keywords
- Pain, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 368 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- European Commission
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 21 Mar 2024 (actual)
- First posted
- 17 Aug 2021 (actual)
- 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.
The purpose of the study is to evaluate the impact of social support and pain coping strategies in the development and evolution of post-surgical pain.
Detailed description
This is a longitudinal study. After giving their informed consent, patients will answer online questionnaires assessing pain and different psychosocial variables at these time points: before surgery, one to three days after surgery, and one, three, and six months after surgery.
The psychosocial variables evaluated are the following ones :
- Depression,
- Anxiety,
- Stress,
- Pain Coping Strategies,
- Social Support,
- Couple Support.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaires | Experimental | Other: QuestionnairesPatients will answer online surveys containing different questionnaires that will evaluate psychosocial variables as well as pain variables. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged over 18 years of age.
- Capacity to understand and voluntarily sign an informed consent form in French.
Key exclusion criteria (5 listed)
- Insufficient French language skills.
- History of psychotic disease.
- History of neurodegenerative pathology.
- History of neurological disease (e.g. stroke)
- Pre-existing pain condition related to the reason for surgery
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 |
|---|---|---|
| QuestionnairesOnline-based questionnaires | Other | Questionnaires |
Primary outcome
Intensity of acute post-surgical pain
Time frame: Three days after surgery
Questions from the Short Form of the Brief Pain Inventory (translated in French) will be used to assess the intensity of the pain on a numeric rating scale (from 0 to 10) during the three days following surgery.
Development of Persistent post-surgical pain, 3 months
Time frame: 3 months after surgery
Using the Short Form of the Brief Pain Inventory, pain will be assessed at three months to determine whether patients will have developed chronic pain.
Persistent post-surgical pain, 6 months
Time frame: 6 months after surgery
Using the Short Form of the Brief Pain Inventory, pain intensity will be assessed at 6 months.
Pain interference
Time frame: 6 months after surgery
Using the Short Form of the Brief Pain Inventory, pain interference on daily activities will be assessed at 6 months.
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 10 Apr 2024.
- Individual participant dataSharing planned: No
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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.
André Mouraux, Ph.D study chair
Université Catholique de Louvain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires in people with Social Support and Coping Behavior, run by Université Catholique de Louvain at 1 site in Belgium.
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 2 inclusion and 5 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 10 Apr 2024. 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 Belgium. 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?
Intensity of acute post-surgical pain (time frame: Three days after surgery). The study lists 4 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 10 Apr 2024; AzTrials last refreshed its copy on 7 Nov 2026.