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NCT Number: NCT07038564

Immune-Nutritional Scores and Sleep Quality After Total Abdominal Hysterectomy

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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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

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).

Primary outcomes

  1. Postoperative Sleep Quality Score

    Time frame: Postoperative first night

    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.

Secondary outcomes

  1. Postoperative Pain Score

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

    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.

  2. Patient Satisfaction Score

    Time frame: Postoperative day 2

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

Study contacts

Contact information is provided by the study sponsor or research team.

ilke dolgun

CONTACT

[email protected]

+905555485632

Sponsors and collaborators

Lead sponsor

Istinye University

Other

Registry information

Official study title

A Clinical Evaluation of the Relationship Between Preoperative Immune-Nutritional Scores and Postoperative Sleep Quality in Women Undergoing Total Abdominal Hysterectomy

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 26, 2025
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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