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Not yet recruitingNCT07038564Updated Jun 26, 2025

Immune-Nutritional Scores and Sleep Quality After Total Abdominal Hysterectomy

An observational study in Immune-Nutritional Indexes (PNI, HALP) and Postoperative Sleep Quality, sponsored by Istinye University. Not yet recruiting. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-06-26.

Sponsored by Istinye University · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 1 month ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 70 Years
Sex
Female
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Study 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.

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Conditions studied

  • Immune-Nutritional Indexes (PNI, HALP)
  • Postoperative Sleep Quality
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In context

Lead sponsor

Istinye University is the lead sponsor of 207 studies on the registry; 88 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Interventions

  • OtherImmune-Nutritional Scoring and Postoperative Sleep Assessment

    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).

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What researchers measure

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.

    Time frame: Postoperative first night

Secondary outcomes

  1. Postoperative Pain Score

    Pain levels will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst pain imaginable). Scores will be recorded at rest and during mobilization on each postoperative day.

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

  2. Patient Satisfaction Score

    Overall patient satisfaction with the perioperative experience will be assessed using a 0-10 numeric rating scale, with higher scores indicating greater satisfaction.

    Time frame: Postoperative day 2

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 21960370 ↗
  • 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. PubMed 37103068 ↗
  • 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. PubMed 36848404 ↗
  • 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.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07038564
Lead sponsor
Istinye University
Responsible party
İlke Dolgun (Assoc. prof, Haseki Training and Research Hospital) — Principal investigator
First posted
Jun 26, 2025
Start date
Jun 25, 2025 (estimated)
Primary completion
Aug 25, 2025 (estimated)
Completion
Sep 15, 2025 (estimated)
Last update
Jun 26, 2025

Study contacts

ilke dolgun
Contact
ilkeser2004@gmail.com
+905555485632

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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