Impact of Complimentary and Alternative Practices on Patient Wellbeing During Rehabilitation
- Conditions
- DepressionStressPainBlood PressureHeart RateAnxiety
- Interventions
- Other: Conscious BreathingOther: Heartfulness MeditationOther: Emotional Freedom Technique
- Registration Number
- NCT05082246
- Lead Sponsor
- WellSpan Health
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- Meets age requirement
- Willing to participate
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pre- and Post- Intervention Emotional Freedom Technique Data will be gathered in participants with pre-intervention and post-intervention comparison. Pre- and Post- Intervention Conscious Breathing Data will be gathered in participants with pre-intervention and post-intervention comparison. Pre- and Post- Intervention Heartfulness Meditation Data will be gathered in participants with pre-intervention and post-intervention comparison.
- Primary Outcome Measures
Name Time Method Improvement in depression Through completion of study, approximately 8 weeks Measurement of depression using the Patient Health Questionnaire-9. PHQ-9 total score for the seven items ranges from 0 to 27, with 1 to 4 indicating minimal depression, 5 to 9 indicating mild depression, 10 to 14 indicating moderate depression, 15 to 19 indicating moderately severe depression, and 20 to 27 indicating severe depression.
Improvement in perceived stress Through completion of study, approximately 8 weeks Measurement of perceived stress using Perceived Stress Scale 14 can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress; scores ranging from 14-26 would be considered moderate stress; and scores ranging from 27-40 would be considered high perceived stress.
Improvement in anxiety Through completion of study, approximately 8 weeks Measurement of anxiety using the Generalized Anxiety Disorder-7 scale. The GAD-7 total score for the seven items ranges from 0 to 21, with 0 to 4 indicating minimal anxiety, 5 to 9 indicating mild anxiety, 10 to 14 indicating moderate anxiety, and 15 to 21 indicating severe anxiety
- Secondary Outcome Measures
Name Time Method Improvement in pain level Day of intervention, approximately 6 hours Measurement of pain using Wong-Baker FACES scale. "No Hurt" is a pain score of zero. "Hurts Little Bit" is a pain score of two. "Hurts Little More" is a pain score of four. "Hurts Even More" is a pain score of six. "Hurts Whole Lot" is a pain score of eight. "Hurts Worst" is a pain score of ten. Each rating has a correlating facial expression.
Improvement in heart rate Day of intervention, approximately 6 hours Measurement of heart rate using pulse oximetry device.
Improvement in skin temperature Day of intervention, approximately 6 hours Measurement of skin temperature using BioSquares™. These adhesive squares are placed on the webbing of participants' skin between the thumb and forefinger. Skin temperature will change the color of the square. Black is temperature of 79 degrees Fahrenheit and indicates tenseness. Red is temperature of 74 degrees Fahrenheit and indicates nervousness. Green is temperature of 87 degrees Fahrenheit and indicates calmness. Blue is temperature of 791 degrees Fahrenheit and indicates a relaxed state.
Improvement in blood pressure Day of intervention, approximately 6 hours Measurement of blood pressure using DynaMap device.
Trial Locations
- Locations (1)
Wellspan Surgery and Rehabilitation Hospital
🇺🇸York, Pennsylvania, United States