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Impact of Complimentary and Alternative Practices on Patient Wellbeing During Rehabilitation

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WellSpan Health

Status

Unknown

Conditions

Depression
Anxiety
Heart Rate
Pain
Blood Pressure
Stress

Treatments

Other: Emotional Freedom Technique
Other: Heartfulness Meditation
Other: Conscious Breathing

Study type

Interventional

Funder types

Other

Identifiers

NCT05082246
1659000

Details and patient eligibility

About

The study's objective is to assess whether CAM methods are feasible and beneficial in the WSRH setting; to assess stress (using the Perceived Stress Scale-14 and using BioSquares™), anxiety (using the Generalized Anxiety Disorder-7 scale), depression (using the Patient Health Questionnaire-9 scale), pain (using the Wong-Baker FACES scale), and vital signs using a multidisciplinary complementary approach with Heartfulness Meditation, Conscious Breathing, and Emotional Freedom Technique - the CAM practices for this study; and, to assess and compare the above scores for each participant just prior to and immediately after each treatment session.

The study hypothesizes that using CAM modalities in the WSRH is both feasible and beneficial in that patient population; the patients receiving the CAM modalities of treatment will show an improvement in the above-mentioned scores compared to participant scores prior to the intervention; and there may also be an improvement in patients' vital signs following the intervention of CAM practices.

Full description

Acute inpatient rehabilitation programs mainly focus on improving the physical wellbeing of the patients with physical and occupational therapies. While these may also have an impact on the mental and emotional wellbeing of the patients, there is not much available as therapies for mental and emotional wellbeing in these patients. In this study, the investigators wish to assess the impact of a structured CAM model practice for patients in rehabilitation program. These services will be offered through trained professionals. Depression and anxiety, stress, sleep, vital signs such as heart rate, blood pressure and pain scores will be studied within the period of study.

The study's objective is to assess whether CAM methods are feasible and beneficial in the WSRH setting; to assess stress (using the Perceived Stress Scale-14 and using BioSquares™), anxiety (using the Generalized Anxiety Disorder-7 scale), depression (using the Patient Health Questionnaire-9 scale), pain (using the Wong-Baker FACES scale), and vital signs using a multidisciplinary complementary approach with Heartfulness Meditation, Conscious Breathing, and Emotional Freedom Technique - the CAM practices for this study; and, to assess and compare the above scores for each participant just prior to and immediately after each treatment session.

The study hypothesizes that using CAM modalities in the WSRH is both feasible and beneficial in that patient population; the patients receiving the CAM modalities of treatment will show an improvement in the above-mentioned scores compared to participant scores prior to the intervention; and there may also be an improvement in patients' vital signs following the intervention of CAM practices.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Meets age requirement
  • Willing to participate

Exclusion criteria

  • Patients who are unwilling to participate in the study will be excluded.
  • Patients who are unable to sit for 30 minutes due to either physical or mental conditions will be excluded.
  • Patients with an active diagnosis or history of bipolar disorder, schizophrenia or post-traumatic stress disorder (PTSD), as determined by the WSRH physiatrists or psychologists will be excluded.
  • Patients with active suicidal thoughts and who are being referred for mental health help will also be excluded.
  • Patients with a Montreal Cognitive Assessment (MOCA) greater than 20 will be excluded.
  • Patients will be excluded who have a history of schizophrenia, schizoaffective disorder, or other primary psychotic disorder, or dysthymia with onset before age 20; current substance use or abuse disorder, eating disorder, obsessive compulsive disorder (OCD), bipolar disorder, acute psychosis, schizophrenia or schizoaffective disorder, cognitive disorder, organic brain damage or mental disorder, pervasive developmental disorder, mental retardation, borderline personality disorder, persistent antisocial behavior, a primary diagnosis of a personality disorder or risk of suicide, chronic depression/dysthymia, major depressive episode, depression secondary to a concurrent medical disorder, and clinically relevant neurological/ somatic illness.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Pre- and Post- Intervention
Other group
Description:
Data will be gathered in participants with pre-intervention and post-intervention comparison.
Treatment:
Other: Conscious Breathing
Other: Emotional Freedom Technique
Other: Heartfulness Meditation

Trial contacts and locations

1

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Central trial contact

Mihir Modi, DO; Teresa Greco, MSN

Data sourced from clinicaltrials.gov

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