Clinical trial NCT05082246: Impact of Complimentary and Alternative Practices on Patient Wellbeing During Rehabilitation
Official title: Impact of Complimentary and Alternative Practices on Patient Wellbeing During Rehabilitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Depression
Stress
Pain
Heart Rate
Blood Pressure
Keywords: Complementary
Alternative
Emotional Freedom Technique
Conscious Breathing
Heartfulness Meditation
Rehabilitation
Tapping
Meditation
Anxiety
Depression
Stress
Pain
Lead sponsor: WellSpan Health
Sponsor class: OTHER
First posted: 2021-10-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study is a pilot designed to assess the quality of experience of patients measured through standardized assessment forms and objective parameters such as vital signs including blood pressure and heart rate. Participants will be compared with their own data for each intervention.

This will be a prospective pilot pre-post study for the duration of eight weeks, or as long as required to obtain 30 participants. If, prior to the study, measurements of blood pressure and heart rate; pain scale ratings; and anxiety, depression and stress scale scores in patients show an overall improvement when compared to the same information taken after the completion of eight week weeks, then it can be concluded that these CAM methods are feasible and beneficial in the rehab setting.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Improvement in anxiety
timeFrame: Through completion of study, approximately 8 weeks
measure: Improvement in depression
timeFrame: Through completion of study, approximately 8 weeks
measure: Improvement in perceived stress
timeFrame: Through completion of study, approximately 8 weeks
Secondary outcomes:
measure: Improvement in heart rate
timeFrame: Day of intervention, approximately 6 hours
measure: Improvement in blood pressure
timeFrame: Day of intervention, approximately 6 hours
measure: Improvement in skin temperature
timeFrame: Day of intervention, approximately 6 hours
measure: Improvement in pain level
timeFrame: Day of intervention, approximately 6 hours
Other outcomes:
Locations:
city: York
country: United States
facility: Wellspan Surgery and Rehabilitation Hospital
state: Pennsylvania
Study officials:
affiliation: WellSpan Health
name: Mihir Modi, DO
role: PRINCIPAL_INVESTIGATOR
References: