Geriatric PatientsNCT06255184
Effect of Serenity Therapy on Symptoms Distress, Coping Styles, and Emotional Regulation Among Geriatric Patients Undergoing Hemodialysis: a Randomized Controlled Trial
A study testing Sernity intervention in people with Geriatric Patients, run by Alexandria University at 2 sites in Egypt.
Trial summary
Our research aims to examine the effect of the serenity therapy on symptoms distress, coping styles, and emotional regulation among geriatric patients undergoing hemodialysis. This study highlights the following question: what is the effect of the serenity therapy on symptoms distress, coping styles, and emotional… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Geriatric Patients
- What is being tested?
- Sernity intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jan 2024to 15 Apr 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being sixty years or more
- Scheduled for two or three weekly hemodialysis sessions for a minimum of three months
- Having previously undergone hemodialysis for at least six months.
Who cannot join
- having kidney transplant or peritoneal dialysis, hearing or vision disorders that could impede communication, previous participation in serenity therapy program, and getting psychiatric or psychosocial treatment
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Faculty of Nursing, Alexandria university
Alexandria
nefertiti Zaki, 01116702221, nefertiti.zaki@alexu.edu.eg
- Recruiting
Hemodialysis unit of the National Medical Institute
Damanhur, El-Behaira Governorate, Egypt.
Nawarra KhirallahAbdElFatah, 01090543550, nawara.kirallah@nur.dmu.edu.eg
About this study
Our research aims to examine the effect of the serenity therapy on symptoms distress, coping styles, and emotional regulation among geriatric patients undergoing hemodialysis. This study highlights the following question: what is the effect of the serenity therapy on symptoms distress, coping styles, and emotional regulation among geriatric patients undergoing hemodialysis.
Read the detailed description
In order to conduct this study, a randomized controlled trial research design was followed. The selected sitting for this study was the hemodialysis unit of the National Medical Institute at Damanhur city, El-Behaira Governorate, Egypt. Geriatric patients who were recruited for this study, meet the following inclusion criteria; being sixty years or more, scheduled for two or three weekly hemodialysis sessions for a minimum of three months, and having previously undergone hemodialysis for at least six months.
- Conditions
- Geriatric Patients
- Being tested
- Sernity intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sernity interventionBehavioural
Serenity Therapy is a holistic intervention that boosts psychological well-being and emotional balance through relaxation techniques, mindfulness, and guided imagery
| Study group | Role | What they receive |
|---|---|---|
| Serenity GROUP | Experimental | 40 geriatric patients for the serenity group. They will receive the routine care in addition to the serenity therapy which included 8 sessions (1 introductory session, 4 face to face sessions at dialysis unit , and 3 mobile based sessions at home). Receives: Behavioral: Sernity intervention |
| Control group | No intervention | The control group received only the routine care provided at the dialysis unit with no extra interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodialysis Symptoms Distress-22 scale
The Hemodialysis Symptoms Distress scale-22 (HSD-22) is developed by Chen et al. (2021) to determine the symptom clusters that HD patients experience. It consists of 22 items that are classified into five subscales: sleep disturbance, musculoskeletal discomfort, cardiopulmonary distress, inadequate energy/vitality, and gastrointestinal distress.
Measured: 3 months
Coping Orientation to Problems Experienced Inventory
A 28-item self-report inventory called the Brief COPE Scale was developed by Carver (1997) to assess the various coping mechanisms and responses that an individual may utilize during a stressful life situation including dangerous diseases.
Measured: 3 months
The Emotion Regulation Questionnaire
It is a 10-item questionnaire used to assess participants' tendency to control their emotions using two subscales; cognitive reappraisal (6 items) and expressive suppression (4 items) (Gross\& John, 2003).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start1 Jan 2024
- Primary completion1 Apr 2024 (estimated)
- Study completion15 Apr 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 Geriatric PatientsStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Khedr, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06255184
- Sponsor's protocol ID
- 93/2024
- Status last verified
- Feb 2024
- First submitted
- 4 Feb 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abd El Fatah NK, Khedr MA, Elzohairy NW, Harfoush MS, Elgarhy SMA. Effect of serenity therapy on symptoms distress, coping styles, and emotional regulation among geriatric patients undergoing hemodialysis: A randomized controlled trial. Geriatr Nurs. 2026 Apr;69:103863. doi: 10.1016/j.gerinurse.2026.103863. Epub 2026 Jan 21.
PubMed 41570623
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Serenity Therapy on Symptoms Distress, Coping Styles, and Emotional Regulation Among Geriatric Patients Undergoing Hemodialysis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06255184
- Acronym / sponsor ID
- 93/2024
- Conditions
- Geriatric Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 15 Apr 2024 (estimated)
- First posted
- 13 Feb 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.
Our research aims to examine the effect of the serenity therapy on symptoms distress, coping styles, and emotional regulation among geriatric patients undergoing hemodialysis. This study highlights the following question: what is the effect of the serenity therapy on symptoms distress, coping styles, and emotional regulation among geriatric patients undergoing hemodialysis.
Detailed description
In order to conduct this study, a randomized controlled trial research design was followed. The selected sitting for this study was the hemodialysis unit of the National Medical Institute at Damanhur city, El-Behaira Governorate, Egypt. Geriatric patients who were recruited for this study, meet the following inclusion criteria; being sixty years or more, scheduled for two or three weekly hemodialysis sessions for a minimum of three months, and having previously undergone hemodialysis for at least six months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serenity GROUP | Experimental | Behavioral: Sernity intervention40 geriatric patients for the serenity group. They will receive the routine care in addition to the serenity therapy which included 8 sessions (1 introductory session, 4 face to face sessions at dialysis unit , and 3 mobile based sessions at home). |
| Control group | No intervention | –The control group received only the routine care provided at the dialysis unit with no extra interventions. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being sixty years or more
- Scheduled for two or three weekly hemodialysis sessions for a minimum of three months
- Having previously undergone hemodialysis for at least six months.
Key exclusion criteria (1 listed)
- having kidney transplant or peritoneal dialysis, hearing or vision disorders that could impede communication, previous participation in serenity therapy program, and getting psychiatric or psychosocial treatment
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 |
|---|---|---|
| Sernity interventionSerenity Therapy is a holistic intervention that boosts psychological well-being and emotional balance through relaxation techniques, mindfulness, and guided imagery | Behavioural | Serenity GROUP |
Primary outcome
Hemodialysis Symptoms Distress-22 scale
Time frame: 3 months
The Hemodialysis Symptoms Distress scale-22 (HSD-22) is developed by Chen et al. (2021) to determine the symptom clusters that HD patients experience. It consists of 22 items that are classified into five subscales: sleep disturbance, musculoskeletal discomfort, cardiopulmonary distress, inadequate energy/vitality, and gastrointestinal distress.
Coping Orientation to Problems Experienced Inventory
Time frame: 3 months
A 28-item self-report inventory called the Brief COPE Scale was developed by Carver (1997) to assess the various coping mechanisms and responses that an individual may utilize during a stressful life situation including dangerous diseases.
The Emotion Regulation Questionnaire
Time frame: 3 months
It is a 10-item questionnaire used to assess participants' tendency to control their emotions using two subscales; cognitive reappraisal (6 items) and expressive suppression (4 items) (Gross\& John, 2003).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Derived from this study: PubMed 41570623Abd El Fatah NK, Khedr MA, Elzohairy NW, Harfoush MS, Elgarhy SMA. Effect of serenity therapy on symptoms distress, coping styles, and emotional regulation among geriatric patients undergoing hemodialysis: A randomized controlled trial. Geriatr Nurs. 2026 Apr;69:103863. doi: 10.1016/j.gerinurse.2026.103863. Epub 2026 Jan 21.
- Individual participant dataSharing planned: No
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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.
Hemodialysis unit of the National Medical Institute
Damanhur, Egypt
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sernity intervention in people with Geriatric Patients, run by Alexandria University at 2 sites 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 3 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 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Hemodialysis Symptoms Distress-22 scale (time frame: 3 months). The study lists 3 primary outcomes in all. 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 NCT06255184, 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 13 Feb 2024.