Postoperative PainPSAM-SEMNCT07389330
Patients' Perceptions of Postoperative Analgesic Monitoring in Elective General Surgery
An observational study of Postoperative Pain and Pain Management, run by Agri Ibrahim Cecen University at 1 site in Turkey (Türkiye).
Trial summary
This study examines how patients perceive postoperative analgesic monitoring during routine care in elective general surgery. Postoperative pain monitoring is a standard nursing practice, but patients may experience it as either supportive or stressful. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Pain Management
- How many people
- 312 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2026to 30 Apr 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients undergoing elective general surgery who are hospitalized postoperatively and receive routine analgesic monitoring as part of standard nursing care in a tertiary university hospital.
Who may be able to join
- Adults aged 18 years or older
- Undergoing elective general surgery requiring postoperative inpatient care
- Receiving routine postoperative analgesic monitoring as part of standard clinical care
- Clinically stable during the postoperative data collection period
- Able to read and communicate in Turkish
- Able and willing to provide written informed consent
Who cannot join
- Emergency or urgent surgical procedures
- Postoperative admission to an intensive care unit
- Requirement for mechanical ventilation
- Documented cognitive impairment, acute delirium, or severe psychiatric illness
- Inability or unwillingness to complete study questionnaires or interviews
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ağrı Training and Research Hospital
AĞRI, Merkez, 04100
About this study
Official title: Patients' Perceptions of Postoperative Analgesic Monitoring in Elective General Surgery: A Mixed-Methods Structural Equation Modeling Study
This study examines how patients perceive postoperative analgesic monitoring during routine care in elective general surgery. Postoperative pain monitoring is a standard nursing practice, but patients may experience it as either supportive or stressful. These perceptions may influence patients' trust in nursing care, anxiety related to monitoring, and willingness to report pain accurately.
The study uses a mixed-methods observational design. In the quantitative phase, patients complete questionnaires about their experiences with pain monitoring, communication with nurses, trust, anxiety, and pain reporting during the first days after surgery. In the qualitative phase, selected patients participate in interviews to further explain and contextualize the survey findings. No changes are made to standard care, and no experimental treatments are used.
Read the detailed description
Postoperative analgesic monitoring is a routine component of nursing care in elective general surgery and is essential for patient safety and effective pain management. Although monitoring practices are intended to support patients, they may also be perceived as stressful or controlling, depending on how they are experienced and communicated. These perceptions may influence psychosocial processes such as trust in nursing care, anxiety related to monitoring, and patients' willingness to disclose pain.
This study is designed as a prospective observational mixed-methods study conducted in elective general surgery wards. No intervention is applied, and all participants receive standard postoperative care according to institutional protocols. The quantitative phase involves patient-reported questionnaires administered during the first 72 hours after surgery. These measures assess perceptions of postoperative analgesic monitoring, trust in nursing care, monitoring-related anxiety, pain disclosure behavior, and perceived quality of nursing communication.
Structural equation modeling is used to examine the relationships among these variables and to test hypothesized pathways between monitoring perceptions and pain disclosure behavior. The qualitative phase consists of in-depth interviews with a purposive subsample of participants selected based on contrasting survey responses. These interviews are used to explain and enrich the quantitative findings by exploring patients' experiences and interpretations of analgesic monitoring and communication.
Quantitative and qualitative findings are integrated during interpretation to provide a comprehensive understanding of how postoperative analgesic monitoring is perceived by patients and how these perceptions may influence communication and behavior related to pain management. The study aims to generate evidence that can inform patient-centered approaches to postoperative analgesic monitoring while maintaining routine clinical practice.
- Conditions
- Postoperative Pain, Pain Management
- Being tested
- No intervention (observational study)
- Keywords
- postoperative analgesic monitoring, elective general surgery, pain disclosure, trust in nursing care, structural equation modeling
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Other
No intervention is applied in this study. Participants receive standard postoperative care, including routine analgesic monitoring, as part of usual clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Elective General Surgery Patients | Adult patients undergoing elective general surgery who receive routine postoperative analgesic monitoring as part of standard clinical care. Receives: Other: No intervention (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Disclosure Behavior
Pain disclosure behavior is measured using the Pain Disclosure Behavior Scale (PDB), a self-report questionnaire consisting of 3 items. Each item is rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Total scores range from 3 to 15, with higher scores indicating greater willingness to report pain accurately and to request analgesia when needed.
Measured: Postoperative days 1 to 3
Secondary outcomes (5)
Trust in Nursing Care
Trust in nursing care is assessed using the Trust in Nursing Care Scale (TNC), a 3-item self-report instrument. Items are rated on a 5-point Likert scale from 1 (very low trust) to 5 (very high trust). Total scores range from 3 to 15, with higher scores indicating greater trust in nursing competence, intentions, and clinical judgment.
Measured: Postoperative days 1 to 3
Monitoring-Related Anxiety
Monitoring-related anxiety is measured using the Monitoring-Related Anxiety Scale (MRA), a 3-item self-report questionnaire. Each item is scored on a 5-point Likert scale from 1 (not anxious at all) to 5 (extremely anxious). Total scores range from 3 to 15, with higher scores indicating greater anxiety related to postoperative analgesic monitoring.
Measured: Postoperative days 1 to 3
Perceived Surveillance-Oriented Analgesic Monitoring
Perceived surveillance-oriented analgesic monitoring is assessed using the Perceived Surveillance of Analgesic Monitoring Scale (PSAM). The scale consists of 3 items rated on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Total scores range from 3 to 15, with higher scores reflecting stronger perceptions of monitoring as controlling or surveillance-oriented.
Measured: Postoperative days 1 to 3
Perceived Supportive Analgesic Monitoring
Perceived supportive analgesic monitoring is measured using the Perceived Supportive Monitoring Scale (PSM), a 3-item self-report instrument. Items are scored on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Total scores range from 3 to 15, with higher scores indicating greater perception of analgesic monitoring as supportive and reassuring.
Measured: Postoperative days 1 to 3
Perceived Nursing Communication Quality
Nursing communication quality is assessed using a validated Nursing Communication Quality Scale consisting of 4 items. Each item is rated on a 5-point Likert scale from 1 (very poor communication) to 5 (excellent communication). Total scores range from 4 to 20, with higher scores indicating better perceived communication quality.
Measured: Postoperative days 1 to 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start15 Feb 2026
- Primary completion15 Apr 2026
- Study completion30 Apr 2026
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 Postoperative PainStudies of the same condition, open and under way.
- 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
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agri Ibrahim Cecen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volkan Gokmen, Agri Ibrahim Cecen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389330
- Sponsor's protocol ID
- PSAM-SEM-2026
- Acronym
- PSAM-SEM
- Status last verified
- May 2026
- First submitted
- 25 Jan 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. The study involves patient-reported perceptions, psychosocial measures, and qualitative interview data collected in a postoperative clinical setting. Sharing IPD could pose a risk to participant confidentiality and privacy. Only aggregated and anonymized results will be reported in publications.
Publications
Gan TJ, Habib AS, Miller TE, White W, Apfelbaum JL. Incidence, patient satisfaction, and perceptions of post-surgical pain: results from a US national survey. Curr Med Res Opin. 2014 Jan;30(1):149-60. doi: 10.1185/03007995.2013.860019. Epub 2013 Nov 15.
PubMed 24237004Salmon P, Manyande A. Good patients cope with their pain: postoperative analgesia and nurses' perceptions of their patients' pain. Pain. 1996 Nov;68(1):63-68. doi: 10.1016/S0304-3959(96)03171-5.
PubMed 9251999Ip HY, Abrishami A, Peng PW, Wong J, Chung F. Predictors of postoperative pain and analgesic consumption: a qualitative systematic review. Anesthesiology. 2009 Sep;111(3):657-77. doi: 10.1097/ALN.0b013e3181aae87a.
PubMed 19672167Qaddumi J, Arda AM, Alkhawaldeh A, ALBashtawy M, Abdalrahim A, ALBashtawy S, Al Omari O, Bashtawi M, Masa'deh R, ALBashtawy Z, Mohammad KI, ALBashtawy B, Aljezawi M, Khatatbeh H, Ta'an W, Suliman M, Al Dameery K, Bani Hani S. Preoperative anxiety, postoperative pain tolerance and analgesia consumption: A prospective cohort study. J Perioper Pract. 2025 Oct;35(10):426-436. doi: 10.1177/17504589241253489. Epub 2024 Aug 6.
PubMed 39104294
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients' Perceptions of Postoperative Analgesic Monitoring in Elective General Surgery: A Mixed-Methods Structural Equation Modeling Study
- ClinicalTrials.gov ID
- NCT07389330
- Acronym / sponsor ID
- PSAM-SEM / PSAM-SEM-2026
- Conditions
- Postoperative Pain, Pain Management
- Keywords
- postoperative analgesic monitoring, elective general surgery, pain disclosure, trust in nursing care, structural equation modeling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Agri Ibrahim Cecen UniversityUniversity, hospital or other
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 15 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 5 Feb 2026 (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 study examines how patients perceive postoperative analgesic monitoring during routine care in elective general surgery. Postoperative pain monitoring is a standard nursing practice, but patients may experience it as either supportive or stressful. These perceptions may influence patients' trust in nursing care, anxiety related to monitoring, and willingness to report pain accurately.
The study uses a mixed-methods observational design. In the quantitative phase, patients complete questionnaires about their experiences with pain monitoring, communication with nurses, trust, anxiety, and pain reporting during the first days after surgery. In the qualitative phase, selected patients participate in interviews to further explain and contextualize the survey findings. No changes are made to standard care, and no experimental treatments are used.
Detailed description
Postoperative analgesic monitoring is a routine component of nursing care in elective general surgery and is essential for patient safety and effective pain management. Although monitoring practices are intended to support patients, they may also be perceived as stressful or controlling, depending on how they are experienced and communicated. These perceptions may influence psychosocial processes such as trust in nursing care, anxiety related to monitoring, and patients' willingness to disclose pain.
This study is designed as a prospective observational mixed-methods study conducted in elective general surgery wards. No intervention is applied, and all participants receive standard postoperative care according to institutional protocols. The quantitative phase involves patient-reported questionnaires administered during the first 72 hours after surgery. These measures assess perceptions of postoperative analgesic monitoring, trust in nursing care, monitoring-related anxiety, pain disclosure behavior, and perceived quality of nursing communication.
Structural equation modeling is used to examine the relationships among these variables and to test hypothesized pathways between monitoring perceptions and pain disclosure behavior. The qualitative phase consists of in-depth interviews with a purposive subsample of participants selected based on contrasting survey responses. These interviews are used to explain and enrich the quantitative findings by exploring patients' experiences and interpretations of analgesic monitoring and communication.
Quantitative and qualitative findings are integrated during interpretation to provide a comprehensive understanding of how postoperative analgesic monitoring is perceived by patients and how these perceptions may influence communication and behavior related to pain management. The study aims to generate evidence that can inform patient-centered approaches to postoperative analgesic monitoring while maintaining routine clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective General Surgery Patients | – | Other: No intervention (observational study)Adult patients undergoing elective general surgery who receive routine postoperative analgesic monitoring as part of standard clinical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients undergoing elective general surgery who are hospitalized postoperatively and receive routine analgesic monitoring as part of standard nursing care in a tertiary university hospital.
Key inclusion criteria (6 listed)
- Adults aged 18 years or older
- Undergoing elective general surgery requiring postoperative inpatient care
- Receiving routine postoperative analgesic monitoring as part of standard clinical care
- Clinically stable during the postoperative data collection period
- Able to read and communicate in Turkish
Key exclusion criteria (5 listed)
- Emergency or urgent surgical procedures
- Postoperative admission to an intensive care unit
- Requirement for mechanical ventilation
- Documented cognitive impairment, acute delirium, or severe psychiatric illness
- Inability or unwillingness to complete study questionnaires or interviews
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 |
|---|---|---|
| No intervention (observational study)No intervention is applied in this study. Participants receive standard postoperative care, including routine analgesic monitoring, as part of usual clinical practice. | Other | Elective General Surgery Patients |
Primary outcome
Pain Disclosure Behavior
Time frame: Postoperative days 1 to 3
Pain disclosure behavior is measured using the Pain Disclosure Behavior Scale (PDB), a self-report questionnaire consisting of 3 items. Each item is rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree). Total scores range from 3 to 15, with higher scores indicating greater willingness to report pain accurately and to request analgesia when needed.
5 secondary outcomes
Trust in Nursing Care
Time frame: Postoperative days 1 to 3
Monitoring-Related Anxiety
Time frame: Postoperative days 1 to 3
Perceived Surveillance-Oriented Analgesic Monitoring
Time frame: Postoperative days 1 to 3
Perceived Supportive Analgesic Monitoring
Time frame: Postoperative days 1 to 3
Perceived Nursing Communication Quality
Time frame: Postoperative days 1 to 3
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 2 Jun 2026.
- Background: PubMed 24237004Gan TJ, Habib AS, Miller TE, White W, Apfelbaum JL. Incidence, patient satisfaction, and perceptions of post-surgical pain: results from a US national survey. Curr Med Res Opin. 2014 Jan;30(1):149-60. doi: 10.1185/03007995.2013.860019. Epub 2013 Nov 15.
- Background: PubMed 9251999Salmon P, Manyande A. Good patients cope with their pain: postoperative analgesia and nurses' perceptions of their patients' pain. Pain. 1996 Nov;68(1):63-68. doi: 10.1016/S0304-3959(96)03171-5.
- Background: PubMed 19672167Ip HY, Abrishami A, Peng PW, Wong J, Chung F. Predictors of postoperative pain and analgesic consumption: a qualitative systematic review. Anesthesiology. 2009 Sep;111(3):657-77. doi: 10.1097/ALN.0b013e3181aae87a.
- Background: PubMed 39104294Qaddumi J, Arda AM, Alkhawaldeh A, ALBashtawy M, Abdalrahim A, ALBashtawy S, Al Omari O, Bashtawi M, Masa'deh R, ALBashtawy Z, Mohammad KI, ALBashtawy B, Aljezawi M, Khatatbeh H, Ta'an W, Suliman M, Al Dameery K, Bani Hani S. Preoperative anxiety, postoperative pain tolerance and analgesia consumption: A prospective cohort study. J Perioper Pract. 2025 Oct;35(10):426-436. doi: 10.1177/17504589241253489. Epub 2024 Aug 6.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. The study involves patient-reported perceptions, psychosocial measures, and qualitative interview data collected in a postoperative clinical setting. Sharing IPD could pose a risk to participant confidentiality and privacy. Only aggregated and anonymized results will be reported in publications.
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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 Postoperative Pain and Pain Management, run by Agri Ibrahim Cecen University at 1 site in Turkey (Türkiye).
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 2 Jun 2026. 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 Turkey (Türkiye). 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?
Pain Disclosure Behavior (time frame: Postoperative days 1 to 3). 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 NCT07389330, 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 2 Jun 2026.