Health-related Quality of LifeNCT07579819
Enhancing Health-related Quality of Life, Emotional Well-being and Reducing Anxiety: Integrated Psychoeducational Nursing Interventions in Patients Undergoing Modified Electroconvulsive Therapy
A study testing - 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 in people with Health-related Quality of Life and Emotional Well-being, run by Shereen at 1 site in Egypt.
Trial summary
Background: Electroconvulsive Therapy (ECT) remains a highly effective intervention for severe psychiatric disorders yet concerns about cognitive and emotional side effects persist. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Health-related Quality of Life, Emotional Well-being, Modified Electroconvulsive Therapy
- What is being tested?
- - 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
- 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
- 15 Jan 2026to 22 Apr 2026
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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. .
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- - 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, No intervention (observational study)
- Keywords
- Modified Electroconvulsive Therapy, Health-related Quality of Life, anxiety, Emotional Well-being
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
- After baseline measurement, the 120 patients were randomly divided into two equal groups: Study (Intervention) group (n = 60): received the multidisciplinary psychiatric nursing intervention sessionBehavioural
no session will be given to the control group unless all the study data collected
No intervention (observational study)Behavioural
Also called control group
control group will not receive the sessions unless the study is completed
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: No intervention (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Secondary outcomes (1)
Emotional Well-Being
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
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start15 Jan 2026
- Primary completion19 Apr 2026
- Study completion22 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health-related Quality of LifeStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shereen
- Sponsor type
- University, hospital or other
- Collaborators
- Menoufia University
- Responsible party
- Sponsor-investigator, Shereen, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07579819
- Sponsor's protocol ID
- ERCNMA1000/4/1/193/26
- Status last verified
- May 2026
- First submitted
- 1 May 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Health-related Quality of Life, Emotional Well-being and Reducing Anxiety: Integrated Psychoeducational Nursing Interventions in Patients Undergoing Modified Electroconvulsive Therapy
- ClinicalTrials.gov ID
- NCT07579819
- Acronym / sponsor ID
- ERCNMA1000/4/1/193/26
- Keywords
- Modified Electroconvulsive Therapy, Health-related Quality of Life, anxiety, Emotional Well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- ShereenUniversity, hospital or other
- Collaborators
- Menoufia University
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 19 Apr 2026 (actual)
- Study completion
- 22 Apr 2026 (actual)
- First posted
- 12 May 2026 (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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study groups mindfulness | Experimental | 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 sessionwill 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 |
| control group routine care | Experimental | Behavioral: No intervention (observational study)will not receive the sessions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- Diagnosed with dementia or severe cognitive impairment, Neurological conditions affecting cognition,
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| - After baseline measurement, the 120 patients were randomly divided into two equal groups: Study (Intervention) group (n = 60): received the multidisciplinary psychiatric nursing intervention sessionno session will be given to the control group unless all the study data collected | Behavioural | study groups mindfulness |
| No intervention (observational study)Also: control groupcontrol group will not receive the sessions unless the study is completed | Behavioural | control group routine care |
Primary outcome
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
1 secondary outcome
Emotional Well-Being
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing - 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 in people with Health-related Quality of Life and Emotional Well-being, run by Shereen 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 8 inclusion and 0 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: finished, as of the sponsor's last update on 12 May 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in quality of life (time frame: 8 weeks). 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 12 May 2026.