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NCT Number: NCT07007013

Impact of Humor Prescription on the Emotional Well-being of Patients With Medically Unexplained Symptoms: A Quasi-experimental 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)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Medically Unexplained Symptoms Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CAPI Baix A Mar (CSAPG)

Vilanova i la Geltrú, Barcelona, 08800, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Humor therapy

Other

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Consorci Sanitari de l'Alt Penedès i Garraf

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jun 5, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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