Substance AbuseHeartMathsubNCT06437366
Nurse-Led Heart Math Training Program With Substance Use Disorder
A study testing Nurse-Led Heart Math Training Program in people with Substance Abuse, run by Alexandria University at 1 site in Egypt.
Trial summary
Substance use disorders (SUDs) pose significant challenges to individuals' psychological well-being, resilience, and emotional adjustment. These disorders often lead to detrimental effects on physical health, mental health, and overall quality of life, creating a critical need for effective interventions that can… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Substance Abuse
- What is being tested?
- Nurse-Led Heart Math Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 1 Aug 2024
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- substance abuse for at least one month
Who cannot join
- out side hospital
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria university
Alexandria, Alexandria Governorate, 21913
mohamed H atta, 2026609088, mohamed-hussein@alexu.edu.com
About this study
Official title: Effectiveness of a Nurse-Led Heart Math Training Program on Resilience , Sense of Coherence, and Emotional Adjustment in Patients With Substance Use Disorder
Substance use disorders (SUDs) pose significant challenges to individuals' psychological well-being, resilience, and emotional adjustment. These disorders often lead to detrimental effects on physical health, mental health, and overall quality of life, creating a critical need for effective interventions that can support recovery and enhance emotional resilience. One promising approach is the implementation of nurse-led HeartMath training programs. These programs utilize evidence-based techniques to improve emotional regulation, increase resilience, and foster a sense of coherence, which is the ability to perceive life as comprehensible, manageable, and meaningful.
Read the detailed description
The HeartMath training program, developed by the HeartMath Institute, focuses on teaching individuals self-regulation skills that promote heart-brain coherence. This state of coherence has been associated with improved cognitive function, emotional stability, and physical health. By integrating this training into the care of patients with SUDs, nurses can play a pivotal role in addressing the complex emotional and psychological needs of this population.
Brief About the Training Program
The nurse-led HeartMath training program consists of several key components designed to enhance resilience, sense of coherence, and emotional adjustment:
Heart-Focused Breathing Techniques: Patients are taught specific breathing techniques that help synchronize heart and brain activity, leading to a state of physiological coherence.
Emotional Regulation Skills: The training includes exercises that help individuals recognize and shift from negative to positive emotional states, thereby improving emotional stability and reducing stress.
Biofeedback Technology: Participants use HeartMath biofeedback devices that provide real-time feedback on their heart rhythm patterns, enabling them to monitor and improve their coherence levels.
Resilience-Building Exercises: The program incorporates activities and practices aimed at enhancing personal resilience, such as positive visualization and the cultivation of gratitude and appreciation.
Individual and Group Sessions: The training is delivered through a combination of individual coaching and group workshops, providing both personalized support and a sense of community.
- Conditions
- Substance Abuse
- Being tested
- Nurse-Led Heart Math Training Program
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Led Heart Math Training ProgramBehavioural
he nurse-led HeartMath training program consists of several key components designed to enhance resilience, sense of coherence, and emotional adjustment:
Heart-Focused Breathing Techniques: Patients are taught specific breathing techniques that help synchronize heart and brain activity, leading to a state of physiological coherence.
Emotional Regulation Skills: The training includes exercises that help individuals recognize and shift from negative to positive emotional states, thereby improving emotional stability and reducing stress.
| Study group | Role | What they receive |
|---|---|---|
| nurse-led HeartMath training program on patients with substance use disorder | Experimental | The HeartMath training program, developed by the HeartMath Institute, focuses on teaching individuals self-regulation skills that promote heart-brain coherence. This state of coherence has been associated with improved cognitive function, emotional stability, and physical health. By integrating this training into the care of patients with SUDs, nurses can play a pivotal role in addressing the complex emotional and psychological needs of this population. Receives: Behavioral: Nurse-Led Heart Math Training Program |
| Non-experimental patients with substance use disorder | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients with substance use disorder who participate in a nurse-led HeartMath training program
Patients with substance use disorder who participate in a nurse-led HeartMath training program will show a statistically significant increase in resilience, as measured by the Connor-Davidson Resilience Scale (CD-RISC), compared to those who do not participate in the program.
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start1 Jul 2024 (estimated)
- Primary completion30 Jul 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance AbuseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437366
- Sponsor's protocol ID
- 100.a
- Acronym
- HeartMathsub
- Status last verified
- May 2024
- First submitted
- 25 May 2024
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Elzohairy NW, Eweida RS, Othman AA, Hammad HA, Ramadan Atta MH. Effectiveness of a Nurse-Led HeartMath Training Program on Resilience, Emotional Adjustment, and Treatment Motivation Among Patients With Substance Use Disorder: A Randomized Control Trial. Worldviews Evid Based Nurs. 2025 Aug;22(4):e70061. doi: 10.1111/wvn.70061.
PubMed 40708166
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Nurse-Led Heart Math Training Program on Resilience , Sense of Coherence, and Emotional Adjustment in Patients With Substance Use Disorder
- ClinicalTrials.gov ID
- NCT06437366
- Acronym / sponsor ID
- HeartMathsub / 100.a
- Conditions
- Substance Abuse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 Jul 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 31 May 2024 (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.
Substance use disorders (SUDs) pose significant challenges to individuals' psychological well-being, resilience, and emotional adjustment. These disorders often lead to detrimental effects on physical health, mental health, and overall quality of life, creating a critical need for effective interventions that can support recovery and enhance emotional resilience. One promising approach is the implementation of nurse-led HeartMath training programs. These programs utilize evidence-based techniques to improve emotional regulation, increase resilience, and foster a sense of coherence, which is the ability to perceive life as comprehensible, manageable, and meaningful.
Detailed description
The HeartMath training program, developed by the HeartMath Institute, focuses on teaching individuals self-regulation skills that promote heart-brain coherence. This state of coherence has been associated with improved cognitive function, emotional stability, and physical health. By integrating this training into the care of patients with SUDs, nurses can play a pivotal role in addressing the complex emotional and psychological needs of this population.
Brief About the Training Program
The nurse-led HeartMath training program consists of several key components designed to enhance resilience, sense of coherence, and emotional adjustment:
Heart-Focused Breathing Techniques: Patients are taught specific breathing techniques that help synchronize heart and brain activity, leading to a state of physiological coherence.
Emotional Regulation Skills: The training includes exercises that help individuals recognize and shift from negative to positive emotional states, thereby improving emotional stability and reducing stress.
Biofeedback Technology: Participants use HeartMath biofeedback devices that provide real-time feedback on their heart rhythm patterns, enabling them to monitor and improve their coherence levels.
Resilience-Building Exercises: The program incorporates activities and practices aimed at enhancing personal resilience, such as positive visualization and the cultivation of gratitude and appreciation.
Individual and Group Sessions: The training is delivered through a combination of individual coaching and group workshops, providing both personalized support and a sense of community.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nurse-led HeartMath training program on patients with substance use disorder | Experimental | Behavioral: Nurse-Led Heart Math Training ProgramThe HeartMath training program, developed by the HeartMath Institute, focuses on teaching individuals self-regulation skills that promote heart-brain coherence. This state of coherence has been associated with improved cognitive function, emotional stability, and physical health. By integrating this training into the care of patients with SUDs, nurses can play a pivotal role in addressing the complex emotional and psychological needs of this population. |
| Non-experimental patients with substance use disorder | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- substance abuse for at least one month
Key exclusion criteria (1 listed)
- out side hospital
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 |
|---|---|---|
| Nurse-Led Heart Math Training Programhe nurse-led HeartMath training program consists of several key components designed to enhance resilience, sense of coherence, and emotional adjustment: Heart-Focused Breathing Techniques: Patients are taught specific breathing techniques that help synchronize heart and brain activity, leading to a state of physiological coherence. Emotional Regulation Skills: The training includes exercises that help individuals recognize and shift from negative to positive emotional states, thereby improving emotional stability and reducing stress. | Behavioural | nurse-led HeartMath training program on patients with substance use disorder |
Primary outcome
Patients with substance use disorder who participate in a nurse-led HeartMath training program
Time frame: three months
Patients with substance use disorder who participate in a nurse-led HeartMath training program will show a statistically significant increase in resilience, as measured by the Connor-Davidson Resilience Scale (CD-RISC), compared to those who do not participate in the program.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Derived from this study: PubMed 40708166Elzohairy NW, Eweida RS, Othman AA, Hammad HA, Ramadan Atta MH. Effectiveness of a Nurse-Led HeartMath Training Program on Resilience, Emotional Adjustment, and Treatment Motivation Among Patients With Substance Use Disorder: A Randomized Control Trial. Worldviews Evid Based Nurs. 2025 Aug;22(4):e70061. doi: 10.1111/wvn.70061.
Related trials for Substance Abuse
RecruitingObservational study
Treatment Outcomes Under a Standardized Treatment Protocol in Patients Suffered Substance Abuse Related Voiding Dysfunction
Voiding Dysfunction, Substance Abuse
Active, not recruiting
Implementing PrEP for Women Who Inject Drugs
HIV, Intravenous Substance Abuse
Active, not recruiting
The MOUD Plus Pilot: Counseling and Peer Support to Support Retention for Medically Complex Patients With Opioid Use Disorder Seen In Primary Care
Opioid Dependence, Substance Abuse Disorders
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
Recruiting
A SMART Evaluation of an Adaptive Web-based AUD Treatment for Service Members and Their Partners
Alcohol Abuse, Alcohol Use Disorder
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-Led Heart Math Training Program in people with Substance Abuse, run by Alexandria University at 1 site in Egypt.
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 1 inclusion and 1 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 31 May 2024. 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 Egypt. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients with substance use disorder who participate in a nurse-led HeartMath training program (time frame: three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06437366, which also lists 1 linked publication.
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 31 May 2024; AzTrials last refreshed its copy on 28 Oct 2026.