Impact of Complimentary and Alternative Practices on Patient Wellbeing During Rehabilitation

NCT05082246 | Unknown

• 1 other identifier: 1659000
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Improvement in anxiety

  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

  Through completion of study, approximately 8 weeks

• Improvement in depression

  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.

  Through completion of study, approximately 8 weeks

• Improvement in perceived stress

  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.

  Through completion of study, approximately 8 weeks

Secondary Outcomes (4)

• Improvement in heart rate

  Day of intervention, approximately 6 hours

• Improvement in blood pressure

  Day of intervention, approximately 6 hours

• Improvement in skin temperature

  Day of intervention, approximately 6 hours

• Improvement in pain level

  Day of intervention, approximately 6 hours

Study Arms (1)

Pre- and Post- Intervention

OTHER

Data will be gathered in participants with pre-intervention and post-intervention comparison.

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

Interventions

Conscious Breathing OTHER

During the Conscious Breathing session, participants will be asked to sit comfortably and with gently closed eyes. Participants will be guided through several different kinds of breathing techniques, where the will focus will be on the expansion of the chest or abdomen, releasing all tension from the body, and visualizing breathing light into the body.

Pre- and Post- Intervention

Heartfulness Meditation OTHER

During the Heartfulness Meditation session, participants will be asked to sit comfortably and with gently closed eyes. Starting with the feet and working towards the head, participants will be asked to relax each part of the body. Then participants will focus on the heart and imagine it filled with light and love. Participants will sit in this relaxed state for a few minutes to allow all stress and cares to be released.

Pre- and Post- Intervention

Emotional Freedom Technique OTHER

During the Emotional Freedom Technique session, participants will be asked to tap lightly on several acupressure points while saying a variety of statements regarding pain, anxiety, depression or stress. As participants tap on the acupressure points, participants will repeat phrases of affirmation and acceptance, and also talk through how pain, anxiety, depression or stress may cause distress but can learn to release these feelings. participants will be given a picture of where each of the acupressure points lie on the face, chest or head, and will also be given a script of what to say while tapping on each acupressure point. In addition, participants will be given a description of what each acupressure point "means" - its associated organ and what emotion that point helps to release.

Also known as: EFT, Tapping

Pre- and Post- Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets age requirement
• Willing to participate

You may not qualify if:

• 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.

Sponsors & Collaborators

• WellSpan Health: lead

Study Sites (1)

Wellspan Surgery and Rehabilitation Hospital

York, Pennsylvania, 17043, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mihir Modi, DO

  WellSpan Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mihir Modi, DO

CONTACT

717-851-1300; mmodi@wellspan.org

Teresa Greco, MSN

CONTACT

717-846-6890; tgreco2.wellspan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking. All participants will be getting interventions and measurements will be taken pre- and post- intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Family Medicine Physician

Model Details: 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.

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: October 18, 2021
• Study Start: January 15, 2022
• Primary Completion: April 30, 2022
• Study Completion: June 25, 2022
• Last Updated: October 18, 2021

Record last verified: 2021-10

Locations

US (1)