A precise, registry-appropriate answer based on your study:• Postoperative cognitive impairment• Postoperative pain in older adults. F05 — Delirium (postoperative cognitive impairment)G89.18 — Postprocedural pain (postoperative pain)
Conditions
Interventions
Intervention 1: Intervention group: The intervention group will receive a probiotic regimen starting 7 days bef
Sponsors
Gonabad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
60 Years to 85 Years
Inclusion criteria
Inclusion criteria: Age = 60 years Scheduled for elective abdominal surgery (laparoscopic cholecystectomy, inguinal/umbilical hernia repair) Provided written informed consent Ability to complete cognitive assessments No baseline delirium (CAM score = 3) No use of probiotics within 4 weeks prior to surgery No acute or chronic psychiatric disorders
Exclusion criteria
Exclusion criteria: Occurrence of acute surgical complications: severe bleeding, anastomotic leakage, or organ injury Postoperative infection or sepsis Lack of willingness to continue participation Patient-requested discharge before completion of the study period Occurrence of adverse effects related to probiotics (e.g., severe diarrhea requiring discontinuation) Non-adherence to probiotic intake <80% Presence of delirium Presence of acute or chronic medical disorders identified during the semi-structured interview
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: Change in MoCA score (validated Persian version). Timepoint: (day -7 ± 2) to day +14 ± 3. Method of measurement: The first instrument is the Montreal Cognitive Assessment (MoCA), which is used to evaluate cognitive function and consists of 30 items assessing various cognitive domains, including memory, attention, language, visuospatial abilities, and shape recognition. MoCA scores range from 0 to 30, with higher scores indicating better cognitive performance. A score below 26 is considered indicative of cognitive impairment. The instrument has high reliability, with a Cronbach’s alpha of 0.83, and strong diagnostic validity for detecting cognitive impairment (sensitivity 90%, specificity 87%). The Persian version of MoCA has also demonstrated acceptable reliability and validity in previous studies (a = 0.81). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome: Pain intensity measured by NRS. Timepoint: 6 h, 24 h, and 48 h postoperatively. Method of measurement: The second instrument is the Numeric Rating Scale (NRS), which is used to measure postoperative pain intensity. It consists of an 11-point scale (0–10) on which patients rate their pain from “no pain” (0) to “worst possible pain” (10). The NRS is simple, quick, and easy to understand, and it performs well in clinical settings. It has excellent intra-class reliability (ICC = 0.97) and strong concurrent validity. The scale is highly sensitive for detecting clinically meaningful changes in pain and is widely used in postoperative pain studies among older adults (18). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHashem Fathi
Torbate-Heidaria University of Medical Sciences
Outcome results
None listed