Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604455
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Impact of Acupuncture and Integrative Medicine on Patients Quality-of-life During National Emergency and Wartime
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Impact of Acupuncture and Integrative Medicine on Patientsampamp39 Quality-of-life During National Emergency and Wartime in Integrative Oncology and Inpatient Settings
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 patients39 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 httpswwwrandomizerorg to one of the following study groups
Single-modality integrative medicine receiving acupressurerelaxation only Group A
Multi-modality integrative medicine receiving acupressurerelaxation with acupuncture Group B In both study groups the interviews will address quality of life-related concerns including war-related concerns Reassessment of these concerns will be conducted immediately post-treatment 24-hour post treatment and following 3 weeks patients in both groups will be offered weekly integrative medicine treatments during the 3 weeks following the first treatment
Study objectives and purpose The primary study objective is to improve patients39 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 httpswwwrandomizerorg to one of the following study groups
Single-modality integrative medicine receiving acupressurerelaxation only Group A
Multi-modality integrative medicine receiving acupressurerelaxation with acupuncture Group B In both study groups the interviews will address quality of life-related concerns including war-related concerns Reassessment of these concerns will be conducted immediately post-treatment 24-hour post treatment and following 3 weeks patients in both groups will be offered weekly integrative medicine treatments during the 3 weeks following the first treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None