An observational study in Cesarean Section, Postoperative Recovery and Postoperative Pain, sponsored by Bursa City Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Bursa City Hospital · Observational
This prospective observational study will evaluate whether adherence to enhanced recovery after cesarean delivery protocols is associated with postoperative recovery quality in women undergoing elective cesarean delivery under spinal anesthesia. A total of 150 participants will be enrolled. Recovery quality will be assessed using the Turkish version of the Obstetric Quality of Recovery-10 questionnaire at 24 hours after surgery. Pain, opioid use, nausea, mobilization, oral intake, breastfeeding, and patient satisfaction will also be evaluated.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 150 is above the median of 102 across 683 observational studies indexed under Pain, Postoperative.
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Adult pregnant women aged 18 years or older undergoing elective cesarean delivery under spinal anesthesia at Bursa City Hospital, Türkiye. Eligible participants will have American Society of Anesthesiologists physical status II or III and will be enrolled consecutively during the study period.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women undergoing elective cesarean delivery under spinal anesthesia with adherence to 80% or more of enhanced recovery protocol components.
Other: Assessment of Enhanced Recovery Protocol Compliance
Women undergoing elective cesarean delivery under spinal anesthesia with adherence to 60% to 79% of enhanced recovery protocol components.
Other: Assessment of Enhanced Recovery Protocol Compliance
Women undergoing elective cesarean delivery under spinal anesthesia with adherence to less than 60% of enhanced recovery protocol components.
Other: Assessment of Enhanced Recovery Protocol Compliance
Adherence to routinely implemented enhanced recovery after cesarean delivery components will be assessed during the preoperative, intraoperative, and postoperative periods. Each completed component will receive one point, and overall adherence will be calculated as a percentage. No additional interventions will be administered.
Obstetric Quality of Recovery-10 Score
Postoperative recovery quality will be assessed using the Turkish version of the Obstetric Quality of Recovery-10 questionnaire. Total scores range from 0 to 100, with higher scores indicating better recovery.
Time frame: 24 hours after cesarean delivery
Enhanced Recovery Protocol Compliance
Overall compliance with enhanced recovery protocol components will be calculated as the percentage of completed preoperative, intraoperative, and postoperative components.
Time frame: From the preoperative assessment to 24 hours after cesarean delivery
Postoperative Pain Intensity
Pain intensity will be assessed using the Numeric Rating Scale, ranging from 0 to 10, with higher scores indicating greater pain intensity.
Time frame: In the recovery unit and at 2, 6, 12, and 24 hours after cesarean delivery
Rescue Opioid Requirement
The number of participants requiring rescue opioid medication after cesarean delivery will be recorded.
Time frame: During the first 24 hours after cesarean delivery
Total Amsterdam Preoperative Anxiety and Information Scale Score
The overall Amsterdam Preoperative Anxiety and Information Scale score will be calculated. Scores range from 6 to 30, with higher scores indicating greater anxiety and information needs.
Time frame: Before cesarean delivery
Length of Hospital Stay
Duration of hospital stay from the completion of cesarean delivery until formal hospital discharge, measured in hours.
Time frame: From cesarean delivery until hospital discharge, assessed up to 7 days
Preoperative Information Requirement
Preoperative information needs will be evaluated using the information subscale of the Amsterdam Preoperative Anxiety and Information Scale. Scores range from 2 to 10, with higher scores indicating greater information needs.
Time frame: Before cesarean delivery
Preoperative Anxiety
Preoperative anxiety will be evaluated using the anxiety subscale of the Amsterdam Preoperative Anxiety and Information Scale. Scores range from 4 to 20, with higher scores indicating greater anxiety.
Time frame: Before cesarean delivery
Plan to share: No — Individual participant data will not be shared because of participant confidentiality and institutional data protection policies. Only aggregated study results will be published.
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