General AnesthesiaNCT04619979
Preoperative Anxiety on Postoperative Outcome and Sleep Quality in Patients Undergoing Laparoscopic Hysterectomy
An observational study of General Anesthesia and Postoperative Pain, run by Shengjing Hospital at 1 site in China.
Trial summary
Sleep is a naturally occurring state of decreased arousal that is crucial for normal immune and cognitive function. Although surgery and anesthesia techniques have improved in recent years, sleep function and sleep cycles may still be altered perioperatively by surgery and other interventions under general… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- General Anesthesia, Postoperative Pain, Postoperative Sleep Quality
- What is being tested?
- patients undergoing gynecological surgery under general anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 356 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 10 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study enrolled patients undergoing gynecological surgery under general anesthesia at Shengjing Hospital of China Medical University.
The inclusion criteria were:
- age between 18 and 75 years,
- American Society of Anesthesiologists (ASA) medical status I or II,
- laparoscopic hysterectomy, elective operation and surgery lasting 1-3 h.
The exclusion criteria included
- cardiovascular disease,
- chronic use of analgesics,
- chronic use of antidepressants,
- use of sleep-promoting drugs,
- sleep disorders,
- sleep apnea syndrome,
- history of abnormal surgery or recovery from anesthesia,
- psychosis,
- patients with impaired verbal communication,
- unwillingness to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Preoperative Anxiety on Postoperative Outcome and Sleep Quality in Patients Undergoing Laparoscopic Hysterectomy
Sleep is a naturally occurring state of decreased arousal that is crucial for normal immune and cognitive function. Although surgery and anesthesia techniques have improved in recent years, sleep function and sleep cycles may still be altered perioperatively by surgery and other interventions under general anesthesia.Postoperative sleep fragmentation and poor sleep quality not only lead to hyperalgesia and delayed postoperative recovery, but can increase the risk of potential adverse effects, such as cognitive impairment, chronic pain and emotional disturbances, metabolic disorders, and pro-inflammatory changes. General anesthesia is a medically induced state of hyporesponsiveness that resembles natural sleep. Studies have shown that general anesthesia can lead to circadian rhythm time structure dyssynchrony, resulting in postoperative sleep disturbance, characterized by decreases in rapid eye movement (REM) and slow wave sleep (SWS). Previous studies have also reported that age, preoperative comorbidities, and severity of surgical trauma are independent factors associated with postoperative sleep disturbance. In addition, anxiety is an unpleasant sensation that compromises patients' comfort and well-being. A study by Ruis et al. estimated that 25-80% of patients admitted for surgery experienced preoperative anxiety, including fear of surgery and anesthesia-related fears. Furthermore, preoperative anxiety was recognized as a potential and preventable risk factor for severe postoperative pain and postoperative complications such as increased postoperative morbidity and mortality. Given that several prior studies have reported that preoperative anxiety has an effect on postoperative sleep quality in patients undergoing gynecological surgery, this study aimed to investigate the effect of preoperative anxiety on postoperative outcomes and sleep quality in patients undergoing gynecological surgery. Studying these results could enable us to better manage patients during the perioperative period to promote their postoperative recovery.
- Being tested
- patients undergoing gynecological surgery under general anesthesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients undergoing gynecological surgery under general anesthesiaProcedure or surgery
patients undergoing gynecological surgery under general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| preoperative anxiety group | Not described Receives: Procedure: patients undergoing gynecological surgery under general anesthesia | |
| Non-preoperative anxiety group | Not described Receives: Procedure: patients undergoing gynecological surgery under general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
evaluate Numerical Rating Scale score (0: no pain to 10: severe pain)
Measured: 24 hours after surgery
evaluate postoperative sleep quality by using Athens insomnia scale
evaluate postoperative sleep by using Athens insomnia scale(<4: no insomnia; 4-6: suspicious insomnia; >6: insomnia)
Measured: first night before surgery
evaluate postoperative sleep quality by using Athens insomnia scale
evaluate postoperative sleep by using Athens insomnia scale (<4: no insomnia; 4-6: suspicious insomnia; >6: insomnia)
Measured: first night after surgery
evaluate postoperative sleep quality by using Athens insomnia scale
evaluate postoperative sleep by using Athens insomnia scale (<4: no insomnia; 4-6: suspicious insomnia; >6: insomnia)
Measured: third night after surgery
preoperative anxiety score assessed by the Amsterdam preoperative anxiety and information scale (APAIS)".
evaluate the preoperative anxiety score before the surgery, APAIS contains 6 items rated on a five-point Likert scale, which represents two scales: anxiety (items 1, 2, 4, and 5) and need for information (items 3 and 6) Accordingly, the maximal score of the entire APAIS (APAIS-T) is 30 and the one expressing the patient's need for information (APAIS-I) is 10. The maximal score of the two items concerning anxiety about anesthesia (APAIS-A-An) and surgery (APAIS-A-Su) is also 10 each, resulting in a maximal score of 20 for total preoperative anxiety (APAIS-A-T). And APAIS-A-T > 10 was used as a cut-off to define patients with high anxiety, the higher the score, the more serious the pre-operative anxiety is
Measured: baseline (before the surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start1 Oct 2021
- Primary completion1 Mar 2022
- Study completion10 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanchao Yang, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619979
- Sponsor's protocol ID
- Preoperative anxiety and sleep
- Status last verified
- Aug 2022
- First submitted
- 2 Nov 2020
- Last updated
- 17 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Preoperative Anxiety on Postoperative Outcome and Sleep Quality in Patients Undergoing Laparoscopic Hysterectomy
- ClinicalTrials.gov ID
- NCT04619979
- Acronym / sponsor ID
- Preoperative anxiety and sleep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 6 Nov 2020 (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.
Sleep is a naturally occurring state of decreased arousal that is crucial for normal immune and cognitive function. Although surgery and anesthesia techniques have improved in recent years, sleep function and sleep cycles may still be altered perioperatively by surgery and other interventions under general anesthesia.Postoperative sleep fragmentation and poor sleep quality not only lead to hyperalgesia and delayed postoperative recovery, but can increase the risk of potential adverse effects, such as cognitive impairment, chronic pain and emotional disturbances, metabolic disorders, and pro-inflammatory changes. General anesthesia is a medically induced state of hyporesponsiveness that resembles natural sleep. Studies have shown that general anesthesia can lead to circadian rhythm time structure dyssynchrony, resulting in postoperative sleep disturbance, characterized by decreases in rapid eye movement (REM) and slow wave sleep (SWS). Previous studies have also reported that age, preoperative comorbidities, and severity of surgical trauma are independent factors associated with postoperative sleep disturbance. In addition, anxiety is an unpleasant sensation that compromises patients' comfort and well-being. A study by Ruis et al. estimated that 25-80% of patients admitted for surgery experienced preoperative anxiety, including fear of surgery and anesthesia-related fears. Furthermore, preoperative anxiety was recognized as a potential and preventable risk factor for severe postoperative pain and postoperative complications such as increased postoperative morbidity and mortality. Given that several prior studies have reported that preoperative anxiety has an effect on postoperative sleep quality in patients undergoing gynecological surgery, this study aimed to investigate the effect of preoperative anxiety on postoperative outcomes and sleep quality in patients undergoing gynecological surgery. Studying these results could enable us to better manage patients during the perioperative period to promote their postoperative recovery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preoperative anxiety group | – | Procedure: patients undergoing gynecological surgery under general anesthesia |
| Non-preoperative anxiety group | – | Procedure: patients undergoing gynecological surgery under general anesthesia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study enrolled patients undergoing gynecological surgery under general anesthesia at Shengjing Hospital of China Medical University.
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 |
|---|---|---|
| patients undergoing gynecological surgery under general anesthesiapatients undergoing gynecological surgery under general anesthesia | Procedure or surgery | Non-preoperative anxiety group, preoperative anxiety group |
Primary outcome
postoperative pain
Time frame: 24 hours after surgery
evaluate Numerical Rating Scale score (0: no pain to 10: severe pain)
evaluate postoperative sleep quality by using Athens insomnia scale
Time frame: first night before surgery
evaluate postoperative sleep by using Athens insomnia scale(<4: no insomnia; 4-6: suspicious insomnia; >6: insomnia)
evaluate postoperative sleep quality by using Athens insomnia scale
Time frame: first night after surgery
evaluate postoperative sleep by using Athens insomnia scale (<4: no insomnia; 4-6: suspicious insomnia; >6: insomnia)
evaluate postoperative sleep quality by using Athens insomnia scale
Time frame: third night after surgery
evaluate postoperative sleep by using Athens insomnia scale (<4: no insomnia; 4-6: suspicious insomnia; >6: insomnia)
preoperative anxiety score assessed by the Amsterdam preoperative anxiety and information scale (APAIS)".
Time frame: baseline (before the surgery)
evaluate the preoperative anxiety score before the surgery, APAIS contains 6 items rated on a five-point Likert scale, which represents two scales: anxiety (items 1, 2, 4, and 5) and need for information (items 3 and 6) Accordingly, the maximal score of the entire APAIS (APAIS-T) is 30 and the one expressing the patient's need for information (APAIS-I) is 10. The maximal score of the two items concerning anxiety about anesthesia (APAIS-A-An) and surgery (APAIS-A-Su) is also 10 each, resulting in a maximal score of 20 for total preoperative anxiety (APAIS-A-T). And APAIS-A-T > 10 was used as a cut-off to define patients with high anxiety, the higher the score, the more serious the pre-operative anxiety is
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Anesthesia and Postoperative Pain, run by Shengjing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain (time frame: 24 hours after surgery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2022.