AnxietyNCT05082246
Impact of Complimentary and Alternative Practices on Patient Wellbeing During Rehabilitation
A study testing Conscious Breathing, Heartfulness Meditation and Emotional Freedom Technique in people with Anxiety and Depression, run by WellSpan Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression, Stress
- What is being tested?
- Conscious Breathing, Heartfulness Meditation and Emotional Freedom Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2022to 25 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Meets age requirement
- Willing to participate
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Wellspan Surgery and Rehabilitation Hospital
York, Pennsylvania, 17043
Mihir Modi, DO, 717-851-1300, mmodi@wellspan.org
Teresa Greco, MSN, 717-318-6761, tgreco2.wellspan@gmail.com
About this 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.
Read the 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.
- Conditions
- Anxiety, Depression, Stress, Pain, Heart Rate, Blood Pressure
- Being tested
- Conscious Breathing, Heartfulness Meditation, Emotional Freedom Technique
- Keywords
- Complementary, Alternative, Emotional Freedom Technique, Conscious Breathing, Heartfulness Meditation, Rehabilitation, Tapping, Meditation, Anxiety, Depression, Stress, Pain
- Medical subject headings
- Anxiety Disorders, Depression, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conscious BreathingOther
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 MeditationOther
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 TechniqueOther
Also called EFT, Tapping
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre- and Post- Intervention | Other | Data will be gathered in participants with pre-intervention and post-intervention comparison. Receives: Other: Conscious Breathing; Other: Heartfulness Meditation; Other: Emotional Freedom Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: Through completion of study, approximately 8 weeks
Secondary outcomes (4)
Improvement in heart rate
Measurement of heart rate using pulse oximetry device.
Measured: Day of intervention, approximately 6 hours
Improvement in blood pressure
Measurement of blood pressure using DynaMap device.
Measured: Day of intervention, approximately 6 hours
Improvement in skin temperature
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.
Measured: Day of intervention, approximately 6 hours
Improvement in pain level
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.
Measured: Day of intervention, approximately 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start15 Jan 2022 (estimated)
- Primary completion30 Apr 2022 (estimated)
- Study completion25 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WellSpan Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mihir Modi, WellSpan Health
- Investigators
- Mihir Modi, DO, Principal investigator, WellSpan Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082246
- Sponsor's protocol ID
- 1659000
- Status last verified
- Oct 2021
- First submitted
- 15 Jun 2021
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Complimentary and Alternative Practices on Patient Wellbeing During Rehabilitation
- ClinicalTrials.gov ID
- NCT05082246
- Acronym / sponsor ID
- 1659000
- Conditions
- Anxiety, Depression, Stress, Pain, Heart Rate, Blood Pressure
- Keywords
- Complementary, Alternative, Emotional Freedom Technique, Conscious Breathing, Heartfulness Meditation, Rehabilitation, Tapping, Meditation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- WellSpan HealthUniversity, hospital or other
- Study start
- 15 Jan 2022 (estimated)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 25 Jun 2022 (estimated)
- First posted
- 18 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pre- and Post- Intervention | Other | Other: Conscious Breathing, Other: Heartfulness Meditation, Other: Emotional Freedom TechniqueData will be gathered in participants with pre-intervention and post-intervention comparison. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Meets age requirement
- Willing to participate
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conscious BreathingDuring 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. | Other | Pre- and Post- Intervention |
| Heartfulness MeditationDuring 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. | Other | Pre- and Post- Intervention |
| Emotional Freedom TechniqueAlso: EFT, TappingDuring 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. | Other | Pre- and Post- Intervention |
Primary outcome
Improvement in anxiety
Time frame: 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
Improvement in depression
Time frame: 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
Time frame: 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.
4 secondary outcomes
Improvement in heart rate
Time frame: Day of intervention, approximately 6 hours
Improvement in blood pressure
Time frame: Day of intervention, approximately 6 hours
Improvement in skin temperature
Time frame: Day of intervention, approximately 6 hours
Improvement in pain level
Time frame: Day of intervention, approximately 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mihir Modi, DO principal investigator
WellSpan Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conscious Breathing, Heartfulness Meditation and Emotional Freedom Technique in people with Anxiety and Depression, run by WellSpan Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mihir Modi, DO (717-851-1300, mmodi@wellspan.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in anxiety (time frame: Through completion of study, approximately 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2021.