- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07579819
Enhancing Health-related Quality of Life, Emotional Well-being and Reducing Anxiety: Integrated Psychoeducational Nursing Interventions in Patients Undergoing Modified Electroconvulsive Therapy
Background: Electroconvulsive Therapy (ECT) remains a highly effective intervention for severe psychiatric disorders yet concerns about cognitive and emotional side effects persist. Integrated psychoeducational psychiatric nursing intervention plays a pivotal role in mitigating these challenges, promoting patient safety, and enhancing therapeutic outcomes. So, this study aimed to evaluate the effectiveness of integrated psychoeducational psychiatric nursing intervention on health-related quality of life, emotional well-being and anxiety in patients receiving modified electroconvulsive therapy. Subjects and method: A quasi-experimental research design was utilized from January 2026 to April 2026. Setting: The study was conducted at two psychiatric inpatient hospitals in shebin elkom, Menoufia Governorate, Egypt. Subjects: A purposive sample of sixty patients was selected from the previously mentioned setting. Tools of data collection: Four valid tools were used in data collection: tool 1: A structured interview questionnaire to assess socio-demographic characteristics of the studied subjects, tool 2: The Short Form 36 Health Survey (SF-36) that measures the health-related quality of life of patients with various diseases, tool 3: The Emotional Well-Being Scale (EWBS) is a psychological assessment tool developed to evaluate individual emotional experiences and their overall affective well-being, tool 4: Beck Anxiety Inventory (BAI) to measure the severity of anxiety symptoms in adults and adolescents. Data was analyzed at two points: pre- and post-intervention.
. Recommendations: Integrate psychoeducational psychiatric nursing intervention as a standard component of care for patients undergoing Modified Electroconvulsive Therapy (ECT) to enhance cognitive outcomes and emotional well-being.
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Shibīn al Kawm, Egypt
- Faculty of Nursing
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- Adults aged 18-65 years,
- diagnosed with major depressive disorder, bipolar disorder, or schizophrenia, - scheduled first time to receive MECT treatment for the first time or had not received MECT for more than six months;
- had no history of substance abuse, organic brain disease, or other severe physical illness;
- and had no contraindications for MECT, such as cardiovascular disease, intracranial hypertension, or epilepsy and able to provide informed consent.
The exclusion criteria were:
- Diagnosed with dementia or severe cognitive impairment, Neurological conditions affecting cognition,
- refusal to participate or inability to complete assessments, dropout, or discontinuation of MECT during the study;
- and occurrence of serious adverse events or complications during the study. .
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: study groups mindfulness
will receive the sessions, The integrated psychoeducational psychiatric nursing intervention to effectively enhances health related quality of life, emotional well-being and reduces anxiety in patients receiving modified electroconvulsive therapy
|
no session will be given to the control group unless all the study data collected
|
|
Experimental: control group routine care
will not receive the sessions
|
control group will not receive the sessions unless the study is completed
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in quality of life
Time Frame: 8 weeks
|
The Short Form 36 Health Survey (SF-36) that measures the health-related quality of life of patients with various diseases higher score mean better quality of life and lower score mean low quality of life
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emotional Well-Being
Time Frame: 8 weeks
|
The Emotional Well-Being Scale (EWBS) is a psychological assessment tool developed to evaluate individual emotional experiences and their overall affective well-being, higher score means good Emotional Well-Being and lower score means low Emotional Well-Being
|
8 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ERCNMA1000/4/1/193/26
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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