An interventional study of acupressure/relaxation with acupuncture and acupressure/relaxation in Supportive Care, sponsored by Carmel Medical Center. Recruiting at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Carmel Medical Center · Not applicable, Interventional, and Supportive care
The current ongoing war in Israel, which began in October 2023 with a risk for spreading regionally across the Middle East, has presented a significant challenge to many patients, affecting also those receiving active oncology treatment. The present study examines a unique setting of care involving a diverse population of patients, including those receiving oncology treatment, from a widely diverse social, cultural and religious, background. Patients are offered integrative medicine treatments for 3 weeks with the goal of addressing war-related physical, emotional, and other quality of life-related concerns. After signing the informed consent form, patients will be randomly allocated to one of the two study interventions: acupressure-relaxation alone (Group A); or acupressure-relaxation modalities with acupuncture (Group B). The response to the study intervention for quality of life-related concerns will be re-assessed immediately; at 24-48 hours; and after 3 weeks following the treatment. Patients will also undergo objective measurements during treatment using Heart Rate Variability (HRV) to determine the impact of the intervention on their QoL and concerns.
Integrative medicine is increasingly being included in supportive and palliative care, primarily in oncology settings. The current military conflict in Israel has led to a surge in cases of emotional and physical distress, overwhelming the health profession throughout the country.
Study objectives and purpose: The primary study objective is to improve patients\' QoL-related concerns including those affected by the military conflict.
Study design and setting: The study is taken place within a prospective randomized controlled methodology.
Study population: Patients of either gender, hospitalized for various indications (oncology or not) or undergoing out-patient oncology treatment, age ≥ 18 years.
Allocation to study arms and groups: Participants will be randomly assigned using the "Research Randomizer" online tool (https://www.randomizer.org/) to one of the following study groups:
Carmel Medical Center is the lead sponsor of 119 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Inability to read and provide
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Acupressure/relaxation only
Other: acupressure/relaxation
Acupressure/relaxation with acupuncture
Other: acupressure/relaxation with acupuncture
The acupressure/acupuncture points will be designated based on evidence-based research. For example, clinical guideline-based integrative oncology protocol for pain relief will include the following analgesia-related acupressure/acupuncture points: Liver-3, Taichong; Large-Intestine 4, Hegu; Stomach-36, Zusanli; Pericard-6, Neiguan; Spleen-6, Sanyinjiao; Yin tang; as well as battlefield ear acupuncture points. In both intervention groups, relaxation techniques will be tailored to the patient's quality of life related concerns, with the option of including breathing and guided imagery modalities as well.
The acupressure points will be designated based on evidence-based research. In both intervention groups, relaxation techniques will be tailored to the patient's quality of life related concerns, with the option of including breathing and guided imagery modalities as well.
Assessing patients' quality of life-related concerns using the Measure Yourself Concerns and Wellbeing (MYCAW)
In MYCAW, patients are asked to list and then score (from 0 to 6; 6 is most severe) their 2 most severe quality of life-related concerns
Time frame: Before and immediately following the integrative medicine intervention; at 24-48 hours; and three weeks post-treatment.
Assessment of objective physiological changes during the intervention
Assessment of objective physiological changes during the 30-minute integrative medicine intervention will be conducted using chest-lead electrocardiogram monitoring autonomic heart rate variability (HRV) throughout.
Time frame: During the 30 minutes integrative medicine intervention
Assessing patients' QoL-related concerns using the Edmonton Symptom Assessment Scale (ESAS)
ESAS asks respondents to score a list of 10 QoL-related concerns on a scale from 0 (no symptom) to 10 (worst severity of the symptom).
Time frame: Before and immediately following the integrative medicine intervention; at 24-48 hours; and three weeks post-treatment.
Assessing patients' quality of life-related concerns using the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30)
EORTC QLQ C-30 asks a number of quality of life-related clusters of concerns, from 1 (not at all) to 4 (very much).
Time frame: Before and three weeks post-treatment.
Plan to share: No
Started Aug 2024 (actual). Primary completion is estimated for Dec 2025, 16 months after the start.
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