Quality of LifeNCT06612749
Assessing the Impact of Integrative Medicine on Anxiety and Wellbeing of Healthcare Providers Exposed to Terror or War
A study testing Integrative medicine including manual and/or mind-body treatments in people with Quality of Life, run by Carmel Medical Center at 1 site in Israel.
Trial summary
The study assesses integrative medicine intervention effects on healthcare providers' quality-of-life during wartime. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- What is being tested?
- Integrative medicine including manual and/or mind-body treatments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteIsrael
- Study dates
- 23 Oct 2023to 1 Sep 2025
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthcare providers reporting war-related concerns affecting their quality of life
Who cannot join
- Healthcare providers with no quality-of-life related concerns they attribute to the war r
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Carmel Medical center
Haifa
Sameer Kassem, MD, 972508573244, samirqa@clalit.org.il
About this study
Official title: Assessing the Impact of Integrative Medicine on Anxiety and Wellbeing of Healthcare Providers Exposed Directly or Indirectly to Terror, Trauma or War
The study assesses integrative medicine intervention effects on healthcare providers' quality-of-life during wartime.
Read the detailed description
The study is prospective, non-randomized and non-controlled, and taking place at the Carmel Medical Center in Haifa, northern Israel, from October 2023. The study was launched in proximity with the outbreak of the October 2023 war in the Middle East. As this timing was and is still regarded in Israel as an emergency life-threatening situation and considering the research limitation to healthcare providers only, the Carmel Medical Center Institutional Review Board has exempted the study from requiring written consent from participants, after reviewing the study protocol. However, Participation in the study was voluntary, and no incentive, financial or other was offered.
The hospital administration and department refer healthcare providers (HCPs) to integrative medicine intervention those if reporting emotional, physical, or other QoL concerns directly or indirectly related to the current conflict in Israel. The IM intervention entails a 30-minute treatment session, with an additional 10 minutes allocated for both pre- and post- treatment assessment. IM treatments are individually tailored to the HCP's QoL-related concerns, taking into consideration their willingness to undergo the recommended modalities. In all cases, a multi-modal IM program is recommended, which includes at least one of the following: acupuncture; manual-movement therapies (e.g., acupressure, Anthroposophic medicine touch therapies, reflexology, Qi Gong, and Feldenkrais method); and mind-body medicine (e.g., relaxation and breathing techniques). During these treatments participants are asked to lay on a treatment bed, with relaxed non-paced breathing throughout the session. The IM treatments are provided by IM-trained therapists who work in an integrative oncology setting.
- Conditions
- Quality of Life
- Being tested
- Integrative medicine including manual and/or mind-body treatments
- Keywords
- Resilience, Integrative medicine, Healthcare providers, Acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative medicine including manual and/or mind-body treatmentsOther
Also called Acupuncture, Relaxation, Acupressure
Referred HCPs are recommended a multi-modal IM program, include at least one of the following: acupuncture; manual-movement therapies (e.g., acupressure, Anthroposophic medicine touch therapies, reflexology, Qi Gong, and Feldenkrais method); and mind-body medicine (e.g., relaxation and breathing techniques).
| Study group | Role | What they receive |
|---|---|---|
| Integrative medicine intervention | Experimental | Healthcare providers were treated for 30 minutes with integrative medicine based on manual and mind-body modalities Receives: Other: Integrative medicine including manual and/or mind-body treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing HCPs QoL-related concerns using the Measure Yourself Concerns and Wellbeing (MYCAW).
The MYCAW asks patients to list their two most significant concerns and general feeling of wellbeing (from 0, "doesn't bother me at all"; to 6, "bothers me greatly"). At post-treatment, the HCPs are asked to re-score the two original leading concerns and general well-being, followed by two open-ended questions about "Other things affecting your health"; and "What has been most important for you?" with respect to the IM treatments they had received. In the post-intervention narratives, HCPs are asked to describe the most important aspects of their treatment. HCP narratives are considered as free-text narratives, which may be qualitatively analyzed using ATLAS.Ti software for systematic coding, to identify clusters of emotional-spiritual keywords (ESKs), such as "calming", "release", "relaxation" and "disengagement".
Measured: Before and immediately following the IO intervention; and at 24-48 hours post-treatment.
Assessment of objective physiological changes during the intervention
Assessment of objective physiological changes during the 30-minute intervention are conducted using chest-lead electrocardiogram monitoring autonomic heart rate variability (HRV) throughout the intervention.
Measured: During the 30 minutes intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2024
- Study start23 Oct 2023
- Primary completion31 Mar 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eran Ben-Arye, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06612749
- Sponsor's protocol ID
- 15102023
- Status last verified
- Aug 2024
- First submitted
- 25 Aug 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ben-Arye E, Gressel O, Samuels N, Stein N, Eden A, Vagedes J, Kassem S. Complementary and integrative medicine intervention in front-line COVID-19 clinicians. BMJ Support Palliat Care. 2022 Apr 5:bmjspcare-2021-003333. doi: 10.1136/bmjspcare-2021-003333. Online ahead of print.
PubMed 35383045Vagedes J, Kassem S, Gressel O, Samuels N, Eden A, Ben-Arye E. Parasympathetic Versus Sympathetic Changes in Heart Rate Variability After a Multimodal Integrative Medicine Intervention for Frontline COVID-19 Personnel. Psychosom Med. 2023 Jan 1;85(1):53-60. doi: 10.1097/PSY.0000000000001153. Epub 2022 Nov 9.
PubMed 36346679Kassem S, Vagedes J, Gressel O, Samuels N, Elias S, Ben-Arye E. Spirit and Sense: Autonomic Response to Integrative Medicine Intervention for Health Care Personnel During Wartime. Biopsychosoc Sci Med. 2025 Jul-Aug 01;87(6):380-387. doi: 10.1097/PSY.0000000000001402. Epub 2025 Jun 11.
PubMed 40511976
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of Integrative Medicine on Anxiety and Wellbeing of Healthcare Providers Exposed Directly or Indirectly to Terror, Trauma or War
- ClinicalTrials.gov ID
- NCT06612749
- Acronym / sponsor ID
- 15102023
- Conditions
- Quality of Life
- Keywords
- Resilience, Integrative medicine, Healthcare providers, Acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- 23 Oct 2023 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 25 Sep 2024 (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 study assesses integrative medicine intervention effects on healthcare providers' quality-of-life during wartime.
Detailed description
The study is prospective, non-randomized and non-controlled, and taking place at the Carmel Medical Center in Haifa, northern Israel, from October 2023. The study was launched in proximity with the outbreak of the October 2023 war in the Middle East. As this timing was and is still regarded in Israel as an emergency life-threatening situation and considering the research limitation to healthcare providers only, the Carmel Medical Center Institutional Review Board has exempted the study from requiring written consent from participants, after reviewing the study protocol. However, Participation in the study was voluntary, and no incentive, financial or other was offered.
The hospital administration and department refer healthcare providers (HCPs) to integrative medicine intervention those if reporting emotional, physical, or other QoL concerns directly or indirectly related to the current conflict in Israel. The IM intervention entails a 30-minute treatment session, with an additional 10 minutes allocated for both pre- and post- treatment assessment. IM treatments are individually tailored to the HCP's QoL-related concerns, taking into consideration their willingness to undergo the recommended modalities. In all cases, a multi-modal IM program is recommended, which includes at least one of the following: acupuncture; manual-movement therapies (e.g., acupressure, Anthroposophic medicine touch therapies, reflexology, Qi Gong, and Feldenkrais method); and mind-body medicine (e.g., relaxation and breathing techniques). During these treatments participants are asked to lay on a treatment bed, with relaxed non-paced breathing throughout the session. The IM treatments are provided by IM-trained therapists who work in an integrative oncology setting.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integrative medicine intervention | Experimental | Other: Integrative medicine including manual and/or mind-body treatmentsHealthcare providers were treated for 30 minutes with integrative medicine based on manual and mind-body modalities |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthcare providers reporting war-related concerns affecting their quality of life
Key exclusion criteria (1 listed)
- Healthcare providers with no quality-of-life related concerns they attribute to the war r
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 |
|---|---|---|
| Integrative medicine including manual and/or mind-body treatmentsAlso: Acupuncture, Relaxation, AcupressureReferred HCPs are recommended a multi-modal IM program, include at least one of the following: acupuncture; manual-movement therapies (e.g., acupressure, Anthroposophic medicine touch therapies, reflexology, Qi Gong, and Feldenkrais method); and mind-body medicine (e.g., relaxation and breathing techniques). | Other | Integrative medicine intervention |
Primary outcome
Assessing HCPs QoL-related concerns using the Measure Yourself Concerns and Wellbeing (MYCAW).
Time frame: Before and immediately following the IO intervention; and at 24-48 hours post-treatment.
The MYCAW asks patients to list their two most significant concerns and general feeling of wellbeing (from 0, "doesn't bother me at all"; to 6, "bothers me greatly"). At post-treatment, the HCPs are asked to re-score the two original leading concerns and general well-being, followed by two open-ended questions about "Other things affecting your health"; and "What has been most important for you?" with respect to the IM treatments they had received. In the post-intervention narratives, HCPs are asked to describe the most important aspects of their treatment. HCP narratives are considered as free-text narratives, which may be qualitatively analyzed using ATLAS.Ti software for systematic coding, to identify clusters of emotional-spiritual keywords (ESKs), such as "calming", "release", "relaxation" and "disengagement".
Assessment of objective physiological changes during the intervention
Time frame: During the 30 minutes intervention
Assessment of objective physiological changes during the 30-minute intervention are conducted using chest-lead electrocardiogram monitoring autonomic heart rate variability (HRV) throughout the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Background: PubMed 35383045Ben-Arye E, Gressel O, Samuels N, Stein N, Eden A, Vagedes J, Kassem S. Complementary and integrative medicine intervention in front-line COVID-19 clinicians. BMJ Support Palliat Care. 2022 Apr 5:bmjspcare-2021-003333. doi: 10.1136/bmjspcare-2021-003333. Online ahead of print.
- Background: PubMed 36346679Vagedes J, Kassem S, Gressel O, Samuels N, Eden A, Ben-Arye E. Parasympathetic Versus Sympathetic Changes in Heart Rate Variability After a Multimodal Integrative Medicine Intervention for Frontline COVID-19 Personnel. Psychosom Med. 2023 Jan 1;85(1):53-60. doi: 10.1097/PSY.0000000000001153. Epub 2022 Nov 9.
- Derived from this study: PubMed 40511976Kassem S, Vagedes J, Gressel O, Samuels N, Elias S, Ben-Arye E. Spirit and Sense: Autonomic Response to Integrative Medicine Intervention for Health Care Personnel During Wartime. Biopsychosoc Sci Med. 2025 Jul-Aug 01;87(6):380-387. doi: 10.1097/PSY.0000000000001402. Epub 2025 Jun 11.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrative medicine including manual and/or mind-body treatments in people with Quality of Life, run by Carmel Medical Center at 1 site in Israel.
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 1 inclusion and 1 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 25 Sep 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 Israel. 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 Eran Ben-Arye, MD (+972528709282, ERANBE@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing HCPs QoL-related concerns using the Measure Yourself Concerns and Wellbeing (MYCAW). (time frame: Before and immediately following the IO intervention; and at 24-48 hours post-treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06612749, which also lists 3 linked publications.
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 25 Sep 2024.