Immune-Nutritional Indexes (PNI, HALP)NCT07038564
Immune-Nutritional Scores and Sleep Quality After Total Abdominal Hysterectomy
An observational study of Immune-Nutritional Indexes (PNI, HALP) and Postoperative Sleep Quality, run by Istinye University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Immune-Nutritional Indexes (PNI, HALP), Postoperative Sleep Quality
- What is being tested?
- Immune-Nutritional Scoring and Postoperative Sleep Assessment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 25 Jun 2025to 15 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Clinical Evaluation of the Relationship Between Preoperative Immune-Nutritional Scores and Postoperative Sleep Quality in Women Undergoing 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.
- Being tested
- Immune-Nutritional Scoring and Postoperative Sleep Assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune-Nutritional Scoring and Postoperative Sleep AssessmentOther
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative first night
Secondary outcomes (2)
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.
Measured: Post-anesthesia care unit (PACU), postoperative day 1 and day 2 (rest and mobilization)
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.
Measured: Postoperative day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start25 Jun 2025 (estimated)
- Primary completion25 Aug 2025 (estimated)
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Immune-Nutritional Indexes (PNI, HALP)Studies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlke Dolgun, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038564
- Sponsor's protocol ID
- TAH PNI HALP
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 21960370Ishiguro 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 37103068Farag 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 36848404Para 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of the Relationship Between Preoperative Immune-Nutritional Scores and Postoperative Sleep Quality in Women Undergoing Total Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT07038564
- Acronym / sponsor ID
- TAH PNI HALP
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 25 Jun 2025 (estimated)
- Primary completion
- 25 Aug 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 26 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immune-Nutritional Scoring and Postoperative Sleep AssessmentRoutine 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). | Other | – |
Primary outcome
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.
2 secondary outcomes
Postoperative Pain Score
Time frame: Post-anesthesia care unit (PACU), postoperative day 1 and day 2 (rest and mobilization)
Patient Satisfaction Score
Time frame: Postoperative day 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Results publication: PubMed 21960370Li 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.
- Results publication: PubMed 37103068Ishiguro 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.
- Results publication: PubMed 36848404Farag 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.
- Results publicationPara 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 dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Immune-Nutritional Indexes (PNI, HALP) and Postoperative Sleep Quality, run by Istinye University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ilke dolgun (+905555485632, ilkeser2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Sleep Quality Score (time frame: Postoperative first night). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07038564, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.