Elective Surgery Patients.
Conditions
Interventions
Intervention 1: Intervention group: Implementation of standard CBT-I protocol (4-6 sessions of 60 minutes) including sleep hygiene education, stimulus control, sleep restriction, and cognitive restruc
Sponsors
Kashan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Insomnia diagnosis: Score above the cut-off on the Insomnia Severity Index (ISI) indicating clinical insomnia. Surgery type: Candidate for elective planned surgery (to ensure sufficient time to complete 4 to 6 sessions of the CBT-I protocol prior to surgery). Age: Adult age range (usually 18 to 65 years, depending on the type of surgery)Informed consent: Ability and willingness to provide written consent to participate in the study and adhere to CBT-I training sessions.. Cognitive ability: Ability to read, write, and understand Persian to complete questionnaires and understand the content of the training sessions. Medication stability: Having a consistent medication pattern (especially for sleep-related medications) for the past two weeks.000
Exclusion criteria
Exclusion criteria: Secondary sleep disorders: Diagnosed sleep disorders other than primary insomnia (such as obstructive sleep apnea, severe restless leg syndrome, or narcolepsy). Acute psychological conditions: History of severe untreated psychiatric disorders (such as schizophrenia, bipolar disorder, psychosis, or suicide attempt in the past 6 months). Substance use: Active abuse of alcohol or illicit substances.Severe underlying diseases: Uncontrolled systemic conditions that may directly affect inflammatory response or wound healing (such as uncontrolled diabetes, severe immunodeficiency, or long-term systemic corticosteroid use). Emergency or high-risk surgery: Change in surgical status from elective to emergency, or surgeries with very high risk disrupting the study protocol timeline. Concurrent interventions: Receiving other psychotherapies or behavioral sleep interventions simultaneously during the study period. Pregnancy or breastfeeding: Due to physiological changes in sleep and inflammatory responses during this period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate and quality of surgical wound healing assessed by ASEPSIS scoring system and Southampton wound assessment scale. Timepoint: Day 3, Day 7, and Day 14 post-surgery. Method of measurement: Wound assessment by trained physician or nurse using the ASEPSIS scoring system and Southampton wound assessment scale; higher scores indicate greater impairment in wound healing.;> Level of systemic inflammatory response measured by serum CRP, IL-6, and TNF-a markers. Timepoint: Before CBT-I intervention, and 24 to 72 hours post-surgery. Method of measurement: Measurement of serum levels of CRP, IL-6, and TNF-a from patient blood samples in the laboratory.;Postoperative clinical outcomes including complication severity, recovery quality, and patient satisfaction. Timepoint: At discharge, Day 7, and Day 30 post-surgery. Method of measurement: Complications assessed by Clavien-Dindo classification, recovery by Postoperative Recovery Profile (PRP), and patient satisfaction by Surgical Satisfaction Questionnaire (SSQ-8). | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep quality including sleep latency, sleep duration, sleep disturbances, and daytime functioning. Timepoint: Before CBT-I intervention, day of surgery, and Day 14 post-surgery. Method of measurement: Pittsburgh Sleep Quality Index (PSQI) with 19 items and 7 subscales; total score 0–21; higher scores indicate poorer sleep quality.;Severity of difficulty in sleep onset, sleep maintenance, early awakening, and functional consequences of insomnia. Timepoint: Before CBT-I intervention, day of surgery, and Day 14 post-surgery. Method of measurement: Insomnia Severity Index (ISI) with 7 items on a 5-point Likert scale; higher scores indicate greater insomnia severity.;Level of anxiety and depression in patients before and after surgery as a mediating variable in the intervention pathway. Timepoint: Before intervention, day of surgery, and Days 7, 14, and 30 post-surgery. Method of measurement: Hospital Anxiety and Depression Scale (HADS); higher scores indicate greater severity of anxiety and depression symptoms. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public Contactfarzaneh karimi
Kashan University of Medical Sciences
Outcome results
None listed