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NCT Number: NCT06008873

Association Between Preoperative Insomnia and Postoperative Quality of Recovery : A Prospective Observational Study

Although patients with cancers are prone to insomnia, especially waiting for surgery during hospitalization, and insomnia promotes acute respiratory infections (ARI) and is not conducive to the postoperative quality of recovery (QoR), evidence that preoperative insomnia delays postoperative recovery is still lacking. In this prospective observational study, we enroll 175 non-elderly subjects with abdominal cancer who will undergo non-emergency cancer resection surgery. Insomnia Severity Index scale (ISI) is used to assess the insomnia severity during hospitalization while awaiting surgery. The Quality of Recovery-15 (QoR-15) is used to evaluate the overall recovery after surgery. Meanwhile, wrist watch and sleep diary are used to record sleep. The aim of the study is to investigate the association between preoperative insomnia and postoperative QoR, the association between preoperative insomnia and postoperative ARI,and to describe preoperative sleep traits.

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Key information

Conditions

Sleep Disorder Dyssomnias Mental Disorders Neoplasms Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

About this study

In the single-center, prospective observational study, ISI is used to investigate the perceptive sleep during hospitalization waiting for surgery,and QoR-15 is used to investigate the overall quality of functional recovery at postoperative 1, 3, 7, 14, and 30 days (POD1/3/7/14/30). At the same time, both of ARI within POD30 and neutrophil to lymphocyte ratio(NLR) in peripheral blood perioperation are recorded. The study is divided into four phases: (1) Screening: on the first day of admission, the subjects are screened according to the inclusion and exclusion criteria, and the basic data are collected, including ISI, QoR-15 and depression/anxiety questionnaires, et al. (2) Enrollment (sleep survey during hospitalization waiting for surgery) : ISI is performed in the day of surgery to perceive the severity of insomnia during the whole period of hospitalization waiting for surgery, and objective and subjective sleep are investigated by wrist watch and sleep diary. (3) Surgical and anesthesia period: the key medical data related to surgery, anesthesia and nursing occurred during the operation are recorded. (4) Follow-up: QoR-15 is investigated POD1/3/7/14/30. Meanwhile, both of ARI and NLR are investigated.

The planned enrollment is 175 subjects. No randomized or any protocol-driven treatment is administered to the subjects during the study. The effect size f2 of the independent variable (ISI scores of hospitalization waiting for surgery) on the dependent variable (QoR-15 on POD1) is expected to be 0.1. The number of covariates is predicted to be 46, α is set as two-sided 0.05, and the power is 0.9. The sample size calculated by PASS software is 157 cases. Considering 10% dropout, a sample size of 175 will be required. Data will be presented as mean±standard deviation, median and number (%). Logistic multivariate, or multivariable models will be both performed by statisticians.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1.Voluntarily execute informed consent;
  • 2.Effective linguistic communication and collaboration;
  • 3.No history of mental disorders;
  • 4.Age of 18-64 years old, male or female;
  • 5.BMI 18-30kg/m2;
  • 6.American Society of anesthesiology (ASA) grade 1-2, New York Heart Association(NYHA) grade Ⅰ or Ⅱ;
  • 7.Initial diagnosis of abdominal cancers and the diagnosis has been disclosed to subjects;
  • 8.Non-emergency cancer resection surgery is planned;
  • 9.The planned anesthesia is general anesthesia with endotracheal intubation.

Exclusion criteria

  • 1.Obstructive apnea syndrome, narcolepsy, restless leg/periodic limb movement disorder, sleepwalking disorder, nightmare disorder;
  • 2.Not suitable to participate in the study.

Treatment and study plan

Primary outcomes

  1. Total scores of the questionnaire of Insomnia Severity Scale (ISI) on the day before surgery or the day of surgery

    Time frame: on the day before surgery or the day of surgery

    ISI is used to assess insomnia during the time when waiting for surgery in hospital from the day of admission to the day of surgery.

    ISI is used to assess how satisfied with sleep patterns and psychological distress or impairments in daytime functioning associated with sleep difficulties.

    ISI is filled in by subjects on the day before surgery or the day of surgery. ISI contents 7 items, which item is measured by an 0-4 point rating scale (0="very satisfaction"; 4="very dissatisfaction").

    ISI total scores range from 0 to 28, with higher scores indicating higher severity of insomnia.

  2. Total scores of the questionnaire of 15-item Quality of Recovery scale (QoR-15）on postoperative day 1

    Time frame: on postoperative day 1

    QoR-15 is a patient-reported measure, and is used to assess global recovery quality after surgery physiologically and psychologically.

    QoR-15 is filled on postoperative day 1. QoR-15 contents 15 items, which item is constructed by an 11-point numerical rating scale (for positive items, 0= "none of the time" to 10="all of the time"; for negative items the scoring was reversed). The total scores are ranging from 0(extremely poor QoR) to 150 (excellent QoR).

Secondary outcomes

  1. Sleep-onset latency(min)(resulting from CSD): Distribution frequency of different degrees of sleep latency during the time when waiting for surgery in hospital from the day of admission to the day of surgery

    Time frame: Everyday when waiting for surgery in hospital from the day of admission to the day of surgery

    A Consensus Sleep Diary (CSD) is used to asses subjective sleep quantity everyday when waiting for surgery in hospital from the day of admission to the day of surgery.

    The CSD items assess sleep-onset latency (time taken to fall asleep), the number of awakenings, and the total duration of sleep. Subjects also allow to record factors that could influence sleep, including use of sleep medication.

  2. Numbers of awakenings(resulting from CSD): Distribution of Numbers of awakenings during the time when waiting for surgery in hospital from the day of admission to the day of surgery

    Time frame: Everyday when waiting for surgery in hospital from the day of admission to the day of surgery

    A Consensus Sleep Diary (CSD) is used to asses subjective sleep quantity everyday waiting for surgery in hospital from the day of admission to the day of surgery.

    The CSD items assess sleep-onset latency (time taken to fall asleep), the number of awakenings, and the total duration of sleep. Subjects also allow to record factors that could influence sleep, including use of sleep medication.

  3. Total duration of sleep in night(min)(resulting from CSD): Distribution of total duration of sleep in night during the time when waiting for surgery in hospital from the day of admission to the day of surgery

    Time frame: Everyday when waiting for surgery in hospital from the day of admission to the day of surgery

    A Consensus Sleep Diary (CSD) is used to asses subjective sleep quantity everyday waiting for surgery in hospital from the day of admission to the day of surgery.

    The CSD items assess sleep-onset latency (time taken to fall asleep), the number of awakenings, and the total duration of sleep. Subjects also allow to record factors that could influence sleep, including use of sleep medication.

  4. Sleep influencing factors(resulting from CSD): Distribution of factors that could influence sleep in night when waiting for surgery in hospital from the day of admission to the day of surgery

    Time frame: Everyday when waiting for surgery in hospital from the day of admission to the day of surgery

    A Consensus Sleep Diary (CSD) is used to asses subjective sleep quantity everyday waiting for surgery in hospital from the day of admission to the day of surgery.

    The CSD items assess sleep-onset latency (time taken to fall asleep), the number of awakenings, and the total duration of sleep. Subjects also allow to record factors that could influence sleep, including use of sleep medication.

  5. Total scores of the questionnaire of 15-item Quality of Recovery scale (QoR-15）on postoperative day 3

    Time frame: on postoperative day 3

    QoR-15 is a patient-reported measure, and is used to assess global recovery quality after surgery physiologically and psychologically.

    QoR-15 is filled on postoperative day 1. QoR-15 contents 15 items, which item is constructed by an 11-point numerical rating scale (for positive items, 0= "none of the time" to 10="all of the time"; for negative items the scoring was reversed). The total scores are ranging from 0(extremely poor QoR) to 150 (excellent QoR).

  6. Total scores of the questionnaire of 15-item Quality of Recovery scale (QoR-15）on postoperative day 7

    Time frame: on postoperative day 7

    QoR-15 is a patient-reported measure, and is used to assess global recovery quality after surgery physiologically and psychologically.

    QoR-15 is filled on postoperative day 1. QoR-15 contents 15 items, which item is constructed by an 11-point numerical rating scale (for positive items, 0= "none of the time" to 10="all of the time"; for negative items the scoring was reversed). The total scores are ranging from 0(extremely poor QoR) to 150 (excellent QoR).

  7. Total scores of the questionnaire of 15-item Quality of Recovery scale (QoR-15）on postoperative day 14

    Time frame: on postoperative day 14

    QoR-15 is a patient-reported measure, and is used to assess global recovery quality after surgery physiologically and psychologically.

    QoR-15 is filled on postoperative day 1. QoR-15 contents 15 items, which item is constructed by an 11-point numerical rating scale (for positive items, 0= "none of the time" to 10="all of the time"; for negative items the scoring was reversed). The total scores are ranging from 0(extremely poor QoR) to 150 (excellent QoR).

  8. Total scores of the questionnaire of 15-item Quality of Recovery scale (QoR-15）on postoperative day 30

    Time frame: on postoperative day 30

    QoR-15 is a patient-reported measure, and is used to assess global recovery quality after surgery physiologically and psychologically.

    QoR-15 is filled on postoperative day 1. QoR-15 contents 15 items, which item is constructed by an 11-point numerical rating scale (for positive items, 0="none of the time" to 10="all of the time"; for negative items the scoring was reversed). The total scores are ranging from 0(extremely poor QoR) to 150 (excellent QoR).

  9. Incidence rate of Acute Respiratory Tract Infection (ARTI) within postoperative day 30

    Time frame: within postoperative day 30

    Acute Respiratory Tract Infection (ARTI): including acute upper respiratory infection and acute lower respiratory infection, according to patients self-reporting.

  10. Peripheral blood neutrophil/lymphocyte ratio on postoperative day 1

    Time frame: on postoperative day 1

    Peripheral blood neutrophil/lymphocyte ratio on postoperative day 1 resulting from blood routine examination

  11. Peripheral blood neutrophil/lymphocyte ratio on postoperative day 3

    Time frame: on postoperative day 3

    Peripheral blood neutrophil/lymphocyte ratio on postoperative day 3 from blood routine examination

  12. Peripheral blood neutrophil/lymphocyte ratio on postoperative day 7

    Time frame: on postoperative day 7

    Peripheral blood neutrophil/lymphocyte ratio on postoperative day 7 from blood routine examination

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Registry information

Official study title

Association Between Preoperative Insomnia and Postoperative Quality of Recovery in Non-elderly Patients Undergoing Non-emergency Cancer Resection Surgery: A Prospective Observational Study

Acronym: PIPQoR

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 24, 2023
Registry last updated
Apr 6, 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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