NCT07579819

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 15, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2026

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2026

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 1, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 12, 2026

Completed
Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

May 1, 2026

Last Update Submit

May 6, 2026

Conditions

Keywords

Modified Electroconvulsive TherapyHealth-related Quality of LifeanxietyEmotional Well-being

Outcome Measures

Primary Outcomes (1)

  • change in quality of life

    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 Outcomes (1)

  • Emotional Well-Being

    8 weeks

Study Arms (2)

study groups mindfulness

EXPERIMENTAL

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

Behavioral: - After baseline measurement, the 120 patients were randomly divided into two equal groups: Study (Intervention) group (n = 60): received the multidisciplinary psychiatric nursing intervention session

control group routine care

EXPERIMENTAL

will not receive the sessions

Behavioral: No intervention (observational study)

Interventions

control group will not receive the sessions unless the study is completed

Also known as: control group
control group routine care

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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. .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing

Shibīn al Kawm, Egypt

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

MethodsPopulation GroupsObservationControl Groups

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative TechniquesDemographyPopulation CharacteristicsEpidemiologic Research DesignEpidemiologic MethodsResearch Design

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

May 1, 2026

First Posted

May 12, 2026

Study Start

January 15, 2026

Primary Completion

April 19, 2026

Study Completion

April 22, 2026

Last Updated

May 12, 2026

Record last verified: 2026-05

Locations