NCT06437366

Brief 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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 31, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

May 31, 2024

Status Verified

May 1, 2024

Enrollment Period

29 days

First QC Date

May 25, 2024

Last Update Submit

May 25, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    three months

Study Arms (2)

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.

Behavioral: Nurse-Led Heart Math Training Program

Non-experimental patients with substance use disorder

NO INTERVENTION

Interventions

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.

nurse-led HeartMath training program on patients with substance use disorder

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • substance abuse for at least one month

You may not qualify if:

  • out side hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria university

Alexandria, Alexandria Governorate, 21913, Egypt

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2024

First Posted

May 31, 2024

Study Start

July 1, 2024

Primary Completion

July 30, 2024

Study Completion

August 1, 2024

Last Updated

May 31, 2024

Record last verified: 2024-05

Locations