Organizational Well-being Among Healthcare ProfessionalsNCT07889128
Holistic Approaches for Organizational Well-being of Healthcare Professionals
A study testing Caring Massage, Serenity Room and Combined Serenity Room and Caring Massage in people with Organizational Well-being Among Healthcare Professionals, run by University of Rome Tor Vergata at 1 site in Italy.
Trial summary
The goal of this randomized clinical trial is to find out whether Caring Massage®, a Serenity room, or a combination of the two can improve organizational well-being among healthcare professionals. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Organizational Well-being Among Healthcare Professionals
- What is being tested?
- Caring Massage, Serenity Room and Combined Serenity Room and Caring Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2027to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthcare professional (e.g., nurse, physician, or healthcare technician).
- At least six months of work experience.
- No known allergy to the oil or skin cream used for Caring Massage®.
- No sensory impairment.
- Not taking medication for a mental health condition.
Who cannot join
- Less than six months of work experience.
- Known allergy to a component of the oil or skin cream used for Caring Massage®.
- Sensory impairment.
- Taking medication for a mental health condition.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Emanuele Primavera, RN, MSN, PhD student contact
Italy1 site, 1 recruiting
- Recruiting
University Hospital of Rome Tor Vergata
Roma, Italy
About this study
Official title: Holistic Approaches for Organizational Well-being of Healthcare Professionals: a Randomized Clinical Trial Protocol
The goal of this randomized clinical trial is to find out whether Caring Massage®, a Serenity room, or a combination of the two can improve organizational well-being among healthcare professionals.
The main question it aims to answer is:
Read more
Do healthcare professionals who receive one of these interventions report greater organizational well-being after 15 days than those who continue their usual post-shift routine? Researchers will compare each of the three intervention groups with a control group that receives no additional intervention. They will also assess whether any changes are maintained at the end of the intervention and 30 days later.
Participants will:
Be assigned to Caring Massage®, the Serenity room, an alternating combination of both, or the control group.
If assigned to an intervention group, attend two sessions per week for one month.
Complete questionnaires before the intervention, after 15 and 30 days, and 30 days after the intervention ends.
Read the detailed description
Healthcare professionals face demanding working conditions that may affect their well-being and their experience of work. Interventions to support them often address physical or psychological needs separately. Caring Massage® and the Serenity room offer different approaches to relaxation and well-being, but evidence on their effects on healthcare professionals' organizational well-being remains limited.
The study will examine whether these interventions improve organizational well-being compared with the usual post-shift routine. It will also explore whether combining Caring Massage® and the Serenity room produces greater improvements in work-related stress, workload, burnout, commitment, and job satisfaction than either intervention alone. The researchers will assess whether any observed effects are maintained after the intervention ends.
- Being tested
- Caring Massage, Serenity Room, Combined Serenity Room and Caring Massage
- Keywords
- Organizational well-being, Caring Massage, Holistic Care, Serenity Room
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caring MassageOther
Caring Massage® is a nursing intervention based on intentional, mindful touch and an empathetic caring relationship. A certified nurse will perform the intervention on predefined body areas, including the face, back, shoulders, arms, hands, legs, and feet, according to a standardized protocol. Oil or moisturizing cream will be used to facilitate the massage. Sessions will take place in a dedicated setting that ensures privacy and comfort, after the participant's work shift. Participants will receive eight sessions over one month, twice weekly, lasting up to 30 minutes each, with at least 48 hours between sessions.
Serenity RoomOther
The Serenity room intervention provides controlled multisensory stimulation inspired by Snoezelen principles. The environment includes soft lighting with gradual color changes, ceiling-mounted fiber optics, background music, reduced external noise, and ergonomic seating. Each 30-minute session includes 10 minutes of acclimatization, 10 minutes of seated relaxation, and 10 minutes of gradual reorientation. Trained Psychiatric Rehabilitation Technicians will supervise the sessions and adjust light and sound intensity to individual preferences. Participants will attend eight sessions over one month, twice weekly, after their work shift, with at least 48 hours between sessions.
Combined Serenity Room and Caring MassageOther
The Combined Caring and Multisensory intervention alternates Caring Massage® with Serenity room sessions. Caring Massage® involves intentional, mindful touch delivered by a certified nurse according to a standardized protocol. Serenity room sessions provide controlled multisensory stimulation through soft lighting, background music, and comfortable seating, supervised by trained Psychiatric Rehabilitation Technicians. Participants will attend two sessions per week after their work shift for one month, for a total of eight sessions: four Caring Massage® sessions and four Serenity room sessions. Each session will last up to 30 minutes, with at least 48 hours between sessions.
| Study group | Role | What they receive |
|---|---|---|
| Caring Massage | Experimental | Participants will receive Caring Massage® from a nurse certified in the technique, in a dedicated setting after their work shift. Sessions will take place twice a week for one month, for a total of eight sessions. Each session will last up to 30 minutes. Receives: Other: Caring Massage |
| Serenity Room | Experimental | Participants will use a dedicated Serenity room after their work shift. The room provides controlled lighting, music, and a comfortable seated environment under the supervision of trained Psychiatric Rehabilitation Technicians. Participants will attend two 30-minute sessions per week for one month, for a total of eight sessions. Receives: Other: Serenity Room |
| Combined Caring Massage and Serenity Room | Experimental | Participants will alternate Caring Massage® and Serenity room sessions after their work shift. They will attend two sessions per week for one month, for a total of eight sessions: four Caring Massage® sessions and four Serenity room sessions. Receives: Other: Combined Serenity Room and Caring Massage |
| Usual post-shift | No intervention | Participants will continue their usual post-shift routine and will receive no additional intervention as part of this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in organizational well-being measured by the Short-Form Nursing Organizational Well-Being Questionnaire (QISO)
Organizational well-being will be assessed using the 48-item Short-Form Nursing Organizational Well-Being Questionnaire (QISO). Higher scores indicate a more positive perception of organizational well-being. The primary comparison between each intervention group and the control group is planned at day 15; assessments at day 30 and follow-up will examine whether effects are maintained.
Measured: Baseline, day 15, day 30, and 30 days after the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organizational Well-being Among Healthcare ProfessionalsStudies 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
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacopo Fiorini, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889128
- Sponsor's protocol ID
- 371
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Holistic Approaches for Organizational Well-being of Healthcare Professionals: a Randomized Clinical Trial Protocol
- ClinicalTrials.gov ID
- NCT07889128
- Acronym / sponsor ID
- 371
- Keywords
- Organizational well-being, Caring Massage, Holistic Care, Serenity Room
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 22 Oct 2026 (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 goal of this randomized clinical trial is to find out whether Caring Massage®, a Serenity room, or a combination of the two can improve organizational well-being among healthcare professionals.
The main question it aims to answer is:
Do healthcare professionals who receive one of these interventions report greater organizational well-being after 15 days than those who continue their usual post-shift routine? Researchers will compare each of the three intervention groups with a control group that receives no additional intervention. They will also assess whether any changes are maintained at the end of the intervention and 30 days later.
Participants will:
Be assigned to Caring Massage®, the Serenity room, an alternating combination of both, or the control group.
If assigned to an intervention group, attend two sessions per week for one month.
Complete questionnaires before the intervention, after 15 and 30 days, and 30 days after the intervention ends.
Detailed description
Healthcare professionals face demanding working conditions that may affect their well-being and their experience of work. Interventions to support them often address physical or psychological needs separately. Caring Massage® and the Serenity room offer different approaches to relaxation and well-being, but evidence on their effects on healthcare professionals' organizational well-being remains limited.
The study will examine whether these interventions improve organizational well-being compared with the usual post-shift routine. It will also explore whether combining Caring Massage® and the Serenity room produces greater improvements in work-related stress, workload, burnout, commitment, and job satisfaction than either intervention alone. The researchers will assess whether any observed effects are maintained after the intervention ends.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Caring Massage | Experimental | Other: Caring MassageParticipants will receive Caring Massage® from a nurse certified in the technique, in a dedicated setting after their work shift. Sessions will take place twice a week for one month, for a total of eight sessions. Each session will last up to 30 minutes. |
| Serenity Room | Experimental | Other: Serenity RoomParticipants will use a dedicated Serenity room after their work shift. The room provides controlled lighting, music, and a comfortable seated environment under the supervision of trained Psychiatric Rehabilitation Technicians. Participants will attend two 30-minute sessions per week for one month, for a total of eight sessions. |
| Combined Caring Massage and Serenity Room | Experimental | Other: Combined Serenity Room and Caring MassageParticipants will alternate Caring Massage® and Serenity room sessions after their work shift. They will attend two sessions per week for one month, for a total of eight sessions: four Caring Massage® sessions and four Serenity room sessions. |
| Usual post-shift | No intervention | –Participants will continue their usual post-shift routine and will receive no additional intervention as part of this study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Healthcare professional (e.g., nurse, physician, or healthcare technician).
- At least six months of work experience.
- No known allergy to the oil or skin cream used for Caring Massage®.
- No sensory impairment.
- Not taking medication for a mental health condition.
Key exclusion criteria (4 listed)
- Less than six months of work experience.
- Known allergy to a component of the oil or skin cream used for Caring Massage®.
- Sensory impairment.
- Taking medication for a mental health condition.
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 |
|---|---|---|
| Caring MassageCaring Massage® is a nursing intervention based on intentional, mindful touch and an empathetic caring relationship. A certified nurse will perform the intervention on predefined body areas, including the face, back, shoulders, arms, hands, legs, and feet, according to a standardized protocol. Oil or moisturizing cream will be used to facilitate the massage. Sessions will take place in a dedicated setting that ensures privacy and comfort, after the participant's work shift. Participants will receive eight sessions over one month, twice weekly, lasting up to 30 minutes each, with at least 48 hours between sessions. | Other | Caring Massage |
| Serenity RoomThe Serenity room intervention provides controlled multisensory stimulation inspired by Snoezelen principles. The environment includes soft lighting with gradual color changes, ceiling-mounted fiber optics, background music, reduced external noise, and ergonomic seating. Each 30-minute session includes 10 minutes of acclimatization, 10 minutes of seated relaxation, and 10 minutes of gradual reorientation. Trained Psychiatric Rehabilitation Technicians will supervise the sessions and adjust light and sound intensity to individual preferences. Participants will attend eight sessions over one month, twice weekly, after their work shift, with at least 48 hours between sessions. | Other | Serenity Room |
| Combined Serenity Room and Caring MassageThe Combined Caring and Multisensory intervention alternates Caring Massage® with Serenity room sessions. Caring Massage® involves intentional, mindful touch delivered by a certified nurse according to a standardized protocol. Serenity room sessions provide controlled multisensory stimulation through soft lighting, background music, and comfortable seating, supervised by trained Psychiatric Rehabilitation Technicians. Participants will attend two sessions per week after their work shift for one month, for a total of eight sessions: four Caring Massage® sessions and four Serenity room sessions. Each session will last up to 30 minutes, with at least 48 hours between sessions. | Other | Combined Caring Massage and Serenity Room |
Primary outcome
Change in organizational well-being measured by the Short-Form Nursing Organizational Well-Being Questionnaire (QISO)
Time frame: Baseline, day 15, day 30, and 30 days after the end of the intervention
Organizational well-being will be assessed using the 48-item Short-Form Nursing Organizational Well-Being Questionnaire (QISO). Higher scores indicate a more positive perception of organizational well-being. The primary comparison between each intervention group and the control group is planned at day 15; assessments at day 30 and follow-up will examine whether effects are maintained.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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.
Emanuele Primavera, RN, MSN, PhD student contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caring Massage, Serenity Room and Combined Serenity Room and Caring Massage in people with Organizational Well-being Among Healthcare Professionals, run by University of Rome Tor Vergata at 1 site in Italy.
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 4 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: looking for participants now, as of the sponsor's last update on 22 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacopo Fiorini, Nursing Manager, PhD (+390620902768, jacopo.fiorini@ptvonline.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in organizational well-being measured by the Short-Form Nursing Organizational Well-Being Questionnaire (QISO) (time frame: Baseline, day 15, day 30, and 30 days after the end of 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 22 Oct 2026.