Medically Unexplained SymptomsNCT07007013
Impact of Humor Prescription on the Emotional Well-being of Patients With Medically Unexplained Symptoms: A Quasi-experimental Study
A study testing Humor therapy in people with Medically Unexplained Symptoms, run by Consorci Sanitari de l'Alt Penedès i Garraf at 1 site in Spain.
Trial summary
This study aims to study the effectiveness of the intervention for medically unexplained symptoms(MUS) in terms of changes in emotional well-being before and after the intervention (humor therapy) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medically Unexplained Symptoms
- What is being tested?
- Humor therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2025to 2 Oct 2026
- 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 may be included in the trial if they meet all of the following inclusion criteria:
- Men and women over 18 years of age.
- Diagnosed with the condition under study (see Section 2: Definitions).
- Expected to undergo follow-up for their condition at the study center.
- Ability to participate in the required assessments.
- Legal capacity to provide informed consent.
- Signed informed consent for inclusion in the study, either by the participant or their legal representative.
Who cannot join
- Participants will be excluded if they meet any of the following exclusion criteria:
- Participants diagnosed with any of the following conditions:
- Severe mental health disorder, as determined by the investigator
- Cognitive impairment of any etiology, as recorded in the medical history
- Treatment for the condition under study using community-based resources prescribed in Primary Care within the past 6 months.
- Cognitive or affective disorders that limit the ability to comply with study procedures.
- Participation in another study involving an experimental intervention during the period of the present trial and/or requiring visit schedules that are incompatible with this trial.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to study the effectiveness of the intervention for medically unexplained symptoms(MUS) in terms of changes in emotional well-being before and after the intervention (humor therapy)
- Conditions
- Medically Unexplained Symptoms
- Being tested
- Humor therapy
- Keywords
- Medically unexplained symptoms
- Medical subject headings
- Medically Unexplained Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Humor therapyOther
The intervention consists of a cycle of 8 group sessions (one per week) led by trained professionals specialized in humor ('clown doctors'). Each session will last approximately 90 to 120 minutes
| Study group | Role | What they receive |
|---|---|---|
| humor therapy | Experimental | All participants will receive an intervention based on humor therapy Receives: Other: Humor therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
emotional well-being
Emotional well-being will be measured before-after intervention through the Warwick-Edinburgh Mental Well-being Scale (WEMWBS). Range scale: 14-70. Higher scores indicate greater well-being.
Measured: From baseline to 6 months after ending the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start1 Sep 2025
- Primary completion2 Oct 2026
- Study completion2 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medically Unexplained SymptomsStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i Garraf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarai Cuevas, Principal investigator, CSAPG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007013
- Sponsor's protocol ID
- CSAPG-75
- Status last verified
- Oct 2026
- First submitted
- 28 May 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Humor Prescription on the Emotional Well-being of Patients With Medically Unexplained Symptoms: A Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT07007013
- Acronym / sponsor ID
- CSAPG-75
- Conditions
- Medically Unexplained Symptoms
- Keywords
- Medically unexplained symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i GarrafUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 2 Oct 2026 (actual)
- Study completion
- 2 Oct 2026 (actual)
- First posted
- 5 Jun 2025 (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.
This study aims to study the effectiveness of the intervention for medically unexplained symptoms(MUS) in terms of changes in emotional well-being before and after the intervention (humor therapy)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| humor therapy | Experimental | Other: Humor therapyAll participants will receive an intervention based on humor therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants may be included in the trial if they meet all of the following inclusion criteria:
- Men and women over 18 years of age.
- Diagnosed with the condition under study (see Section 2: Definitions).
- Expected to undergo follow-up for their condition at the study center.
- Ability to participate in the required assessments.
Key exclusion criteria (7 listed)
- Participants will be excluded if they meet any of the following exclusion criteria:
- Participants diagnosed with any of the following conditions:
- Severe mental health disorder, as determined by the investigator
- Cognitive impairment of any etiology, as recorded in the medical history
- Treatment for the condition under study using community-based resources prescribed in Primary Care within the past 6 months.
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 |
|---|---|---|
| Humor therapyThe intervention consists of a cycle of 8 group sessions (one per week) led by trained professionals specialized in humor ('clown doctors'). Each session will last approximately 90 to 120 minutes | Other | humor therapy |
Primary outcome
emotional well-being
Time frame: From baseline to 6 months after ending the intervention
Emotional well-being will be measured before-after intervention through the Warwick-Edinburgh Mental Well-being Scale (WEMWBS). Range scale: 14-70. Higher scores indicate greater well-being.
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 27 Oct 2026.
- Individual participant dataSharing planned: Yes. IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
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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.
Sarai Cuevas principal investigator
CSAPG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Humor therapy in people with Medically Unexplained Symptoms, run by Consorci Sanitari de l'Alt Penedès i Garraf at 1 site in Spain.
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 7 inclusion and 7 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 27 Oct 2026. 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 Spain. 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?
emotional well-being (time frame: From baseline to 6 months after ending the intervention). 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 27 Oct 2026.