Home » Trials » SLCTR/2026/010
Impact of a preoperative health education program on anxiety and postoperative satisfaction among patients undergoing elective surgeries in District General Hospital Embilipitiya
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SLCTR Registration Number
SLCTR/2026/010
Date of Registration
The date of last modification
May 15, 2026
Scientific Title of Trial
Impact of a preoperative health education program on anxiety and postoperative satisfaction among patients undergoing elective surgeries in District General Hospital Embilipitiya
Public Title of Trial
Randomized Controlled Trial on the Impact of a Health Belief Model–Based Structured Preoperative Health Education Program Compared to Standard Care on Preoperative Anxiety and Postoperative Satisfaction among Patients Undergoing Elective Surgeries at District General Hospital Embilipitiya.
Disease or Health Condition(s) Studied
Preoperative anxiety
Scientific Acronym
Public Acronym
None
Brief title
None
Universal Trial Number
U1111-1336-1048
Any other number(s) assigned to the trial and issuing authority
25/EC/80 (Faculty of Medicine, Peardeniya)
What is the research question being addressed?
Does a structured preoperative health education program based on the Health Belief Model (HBM) reduce preoperative anxiety and improve postoperative satisfaction among patients undergoing elective surgery at District General Hospital Embilipitiya compared with routine preoperative care?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Supportive care
Study Phase
Not Available
Intervention(s) planned
The study will be conducted in surgical wards, Gynecology ward, obstetric ward, ENT and OMF ward at District General Hospital Embilipitiya, Sri Lanka.
Method of randomization: simple randomization. Participants will be recruited using a non-probability convenience sampling method from eligible adult patients.
Allocation concealment: opaque envelopes.
The intervention consists of a structured nurse-led preoperative health education program based on the Health Belief Model (HBM) delivered to patients one day before surgery.
The session lasts approximately one hour and includes information about the surgical procedure, anesthesia, postoperative care, and possible complications, supported by visual aids and an interactive question-and-answer session.
The control group will receive routine preoperative care provided by the hospital.
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Inclusion criteria
-Adult patients aged 18 to under 80 years
-Patients scheduled for elective surgical procedures
-Patients admitted to District General Hospital Embilipitiya
-Able to understand Sinhala and provide informed consent
Exclusion criteria
-Patients with diagnosed psychiatric illness or cognitive impairment
-Patients undergoing emergency surgeries
-Patients whose elective surgery is postponed after recruitment
-Patients who have previously participated in another preoperative health education program
Primary outcome(s)
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1.
Preoperative anxiety will be measured using the Sinhala version of the Amsterdam Preoperative Anxiety and Information Scale (APAIS). The combined anxiety score (Sum C) will be calculated by summing the surgery-related and anesthesia-related anxiety items. Higher scores indicate higher levels of anxiety. The primary outcome will be the mean difference in APAIS anxiety scores between the intervention group and the control group after the intervention. . |
[ Baseline: one day before surgery (before intervention) After completion of the preoperative education session and before surgery. ] |
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2.
Postoperative patient satisfaction will be assessed using the Postoperative Patient Satisfaction Questionnaire (PPSQ) developed and culturally adapted for this study. The PPSQ total score ranges from 18 to 90, with higher scores indicating greater satisfaction. The primary outcome will be the mean difference in satisfaction scores between the intervention group and the control group. |
[ Within 24–48 hours after surgery ] |
Secondary outcome(s)
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1.
Demographic and clinical variables collected using a structured questionnaire and analyzed in relation to anxiety and satisfaction scores. |
[ Baseline (preoperative period) ] |
Target number/sample size
72 participant (36 control group and 36 intervention group)
Countries of recruitment
Sri Lanka
Anticipated start date
2026-05-17
Anticipated end date
2026-06-17
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Self-funded / Academic research (MSc in Nursing, University of Peradeniya)
Regulatory approvals
Sub-Committee on Clinical Trials, Ministry of Health, Sri Lanka
Status
Approved
Date of Approval
2025-11-12
Approval number
2025/EC/80
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medical Sciences |
| Institutional Address: | Faculty of Medical Sciences University of Peradeniya Peradeniya Sri Lanka |
| Telephone: | 081-2396361 |
| Email: | chairperson.erc@med.pdn.ac.lk |
Contact person for Scientific Queries/Principal Investigator
K.D.Madhuwanthi
Nursing officer
Faculty of Allied Health Sciences
University of Peradeniya
Peradeniya
Sri Lanka
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0706002798
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kdmadhuemb@gmail.com
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Contact Person for Public Queries
Bimba Ivanthi Wickramarachchi
Senior Lecturer
Department of Nursing,
Faculty of Allied Health Sciences,
University of Ruhuna, Galle.
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+94702512688
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biwickramarachchi@ahs.ruh.ac.lk
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Primary study sponsor/organization
University of Peradeniya
Academic Sponsor (Degree-awarding institution)
Faculty of Allied Health Sciences
University of Peradeniya
Peradeniya
Sri Lanka
+94-81-2065775
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ar@ahs.pdn.ac.lk
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Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Study protocol available
Yes
Protocol version and date
Protocol URL
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
