Recruiting

Complementary Practices

Sponsor:

WellSpan Health

Code:

NCT05082246

Conditions

Anxiety

Depression

Stress

Pain

Heart Rate

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Conscious Breathing

Heartfulness Meditation

Emotional Freedom Technique

Study Details

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

Study ID

NCT05082246

Start date

Jan 15, 2022

Status verified date

Oct, 2021

Completion date

Jun 25, 2022

Anticipated

Primary completion date

Apr 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: Pre- and Post- Intervention

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

Interventions

Conscious Breathing

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.

Heartfulness Meditation

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.

Emotional Freedom Technique

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.

Primary outcome measure

  • Improvement in anxiety [ Time Frame: Through completion of study, approximately 8 weeks ]
  • Improvement in depression [ Time Frame: Through completion of study, approximately 8 weeks ]
  • Improvement in perceived stress [ Time Frame: Through completion of study, approximately 8 weeks ]

Central Contacts and Locations

Central contacts

Mihir Modi, DO

717-851-1300mmodi@wellspan.org

Teresa Greco, MSN

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

Locations

Wellspan Surgery and Rehabilitation Hospital

Recruiting

York, Pennsylvania, United States, 17043

Contacts

Mihir Modi, DO

717-851-1300mmodi@wellspan.org

Teresa Greco, MSN

717-318-6761tgreco2.wellspan@gmail.com

More Information

Sponsor

WellSpan Health

Last update posted

Oct 18, 2021

Last verified

Oct, 2021

Keywords

  • Complementary
  • Alternative
  • Emotional Freedom Technique
  • Conscious Breathing
  • Heartfulness Meditation
  • Rehabilitation
  • Tapping
  • Meditation
  • Anxiety
  • Depression
  • Stress
  • Pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by WellSpan Health on 2021-10-18.