Immune-Nutritional Scores and Sleep Quality After Total Abdominal Hysterectomy

NCT07038564 | Not Yet Recruiting

• 1 other identifier: TAH PNI HALP
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This prospective observational study aims to evaluate the relationship between preoperative immune-nutritional status and postoperative sleep quality in women undergoing total abdominal hysterectomy under general anesthesia. Immune-nutritional scores, including the Prognostic Nutritional Index (PNI) and Hemoglobin-Albumin-Lymphocyte-Platelet (HALP) score, will be calculated using routine preoperative blood parameters. Postoperative sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire (RCSQ). Secondary outcomes include postoperative pain scores and patient satisfaction. The study will enroll 60 patients and seeks to determine whether preoperative physiological markers can predict subjective recovery parameters such as sleep and comfort, potentially contributing to personalized perioperative care.

Conditions

Immune-Nutritional Indexes (PNI, HALP); Postoperative Sleep Quality

Outcome Measures

Primary Outcomes (1)

• Postoperative Sleep Quality Score

  Sleep quality will be measured using the Richards-Campbell Sleep Questionnaire (RCSQ), a validated 5-item instrument assessing sleep depth, latency, number of awakenings, efficiency, and overall quality. Each item is scored from 0 to 100, with higher scores indicating better sleep quality.

  Postoperative first night

Secondary Outcomes (2)

• Postoperative Pain Score

  Post-anesthesia care unit (PACU), postoperative day 1 and day 2 (rest and mobilization)

• Patient Satisfaction Score

  Postoperative day 2

Interventions

Immune-Nutritional Scoring and Postoperative Sleep Assessment OTHER

Routine preoperative laboratory data (hemoglobin, albumin, lymphocyte, platelet) will be used to calculate immune-nutritional scores (HALP, PNI). Postoperative sleep quality will be assessed with the Richards-Campbell Sleep Questionnaire (RCSQ).

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Female participants only. The study population includes women aged 18 to 70 undergoing elective total abdominal hysterectomy under general anesthesia.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of female patients aged 18 to 70 years undergoing elective total abdominal hysterectomy under general anesthesia at Haseki Training and Research Hospital. Participants must have available preoperative laboratory data and be able to complete postoperative questionnaires.

You may qualify if:

• Female patients aged 18-70
• ASA physical status I-III
• Undergoing elective total abdominal hysterectomy under general anesthesia
• Available complete blood count and biochemistry results within 24 hours preoperatively
• Planned to stay at least one night postoperatively
• Sufficient cognitive ability to understand and complete questionnaires
• Provided written informed consent

You may not qualify if:

• History of neurological or psychiatric illness
• Diagnosed sleep disorders
• Current use of sedative or hypnotic medications
• Undergoing additional surgical procedures during operation
• Requiring postoperative intensive care
• Operated under spinal or epidural anesthesia

Sponsors & Collaborators

• Istinye University: lead

Related Publications (4)

• Li J, Guo Q, Ye X, Lin J, Yi C, Mao H, Yang X, Yu X. Prevalence and risk factors of sleep disturbance in continuous ambulatory peritoneal dialysis patients in Guangzhou, southern China. Int Urol Nephrol. 2012 Jun;44(3):929-36. doi: 10.1007/s11255-011-0060-5. Epub 2011 Sep 30.

  PMID: 21960370 RESULT

• Ishiguro T, Aoyama T, Ju M, Kazama K, Fukuda M, Kanai H, Sawazaki S, Tamagawa H, Tamagawa A, Cho H, Hara K, Numata M, Hashimoto I, Maezawa Y, Segami K, Oshima T, Saito A, Yukawa N, Rino Y. Prognostic Nutritional Index as a Predictor of Prognosis in Postoperative Patients With Gastric Cancer. In Vivo. 2023 May-Jun;37(3):1290-1296. doi: 10.21873/invivo.13207.

  PMID: 37103068 RESULT

• Farag CM, Antar R, Akosman S, Ng M, Whalen MJ. What is hemoglobin, albumin, lymphocyte, platelet (HALP) score? A comprehensive literature review of HALP's prognostic ability in different cancer types. Oncotarget. 2023 Feb 25;14:153-172. doi: 10.18632/oncotarget.28367.

  PMID: 36848404 RESULT

• Para E, Uslu N. Cerrahi hastalarında ameliyat sonrası uyku kalitesi ve uyku düzenini etkileyen etmenler. CBU Sağlık Bilimleri Dergisi. 2022;9(3):443-450. doi:10.34087/cbusbed.1034063.

  RESULT

Central Study Contacts

ilke dolgun

CONTACT

+905555485632; ilkeser2004@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. prof

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 26, 2025
• Study Start: June 25, 2025
• Primary Completion: August 25, 2025
• Study Completion: September 15, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share