PainNCT06707597
Patient Interaction Effects on Pain, Anxiety, and Comfort After Orthopedic Surgery
An observational study of Pain and Anxiety, run by Ankara University.
Trial summary
This study aims to evaluate the effects of interaction among patients on pain, anxiety, and comfort after orthopedic surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Patient Interaction Group
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2024to 15 Mar 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of all adult patients who have undergone lower and upper extremity surgery at the relevant state hospital during the study period, meet the inclusion criteria, and voluntarily agree to participate in the study.
Who may be able to join
- To have undergone lower and upper extremity surgery at a state hospital,
- To be over 18 years of age,
- To stay in the hospital for at least one night,
- To agree to participate in the study.
Who cannot join
- Patients who undergo emergency surgical procedures,
- Patients with language barriers, learning difficulties, or cognitive diseases such as dementia that prevent them from completing the questionnaires,
- Patients with epidural or other catheters,
- Patients who do not wish to participate in the study will be excluded from the research.
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: The Effects of Interaction Among Patients on Pain, Anxiety, and Comfort After Orthopedic Surgery
This study aims to evaluate the effects of interaction among patients on pain, anxiety, and comfort after orthopedic surgery.
Read the detailed description
Surgical procedures can cause pain and anxiety in patients, affecting their comfort levels. Orthopedic surgeries, in particular, are associated with high pain levels. For example, common orthopedic procedures like total knee and hip replacement can cause patients to experience severe pain on the first-day post-surgery. In modern surgical practices, pain management requires the combined use of both pharmacological and non-pharmacological methods. Additionally, various stressors in the hospital environment-such as the sounds of medical devices and monitors, and crowded hospital rooms-can create extra stress for orthopedic patients, especially those with limited mobility. Another important factor is the interaction among patients in the same environment. The presence of another patient in the same room can affect not only environmental comfort but also, through "emotional contagion," the patient's emotional state. Emotional contagion is defined as the transfer of emotions from one person to another, and this interaction can trigger patients' pain and anxiety levels. Particularly, patients who have undergone similar surgical experiences may share each other's emotions empathetically, thereby increasing pain and anxiety. This study aims to examine the effects of patient interaction in the same room on pain, anxiety, and comfort in orthopedic patients.
The study population will consist of patients who undergo lower and upper extremity surgeries in the orthopedics and traumatology clinic of a state hospital in Turkey. Patients who undergo the same surgical procedure on the same day and stay in the same room postoperatively, or those who are in single rooms, will form the study sample. To obtain reliable results, at least 128 patients will be required, with 64 patients in the group sharing a room and 64 patients in the single-room control group. The goal is to reach this sample size during the planning and implementation phases of the research. Considering a 10% patient dropout rate, 70 patients in the shared room group and 70 patients in the single room group, for a total of 140 patients, will be included in the study. Patients will be grouped according to lower and upper extremity surgeries, and pairs will be formed for placement in the same rooms. Patients discharged within 24 hours will be evaluated during their hospital stay. Additionally, a control group of patients in single rooms will be included to assess the impact of staying in the same room.
Before surgery, the patients' trait anxiety levels will be measured using the State-Trait Anxiety Inventory. After the surgery, once patients are placed in their rooms, pain will be assessed at 1, 4, 8, 12, 16, and 24 hours using the Visual Analog Scale for pain at the surgical site, back, and head/neck. Also, at 1, 8, and 24 hours, their state anxiety and immobilization comfort will be evaluated.
- Being tested
- Patient Interaction Group
- Keywords
- pain, anxiety, comfort, orthopedic surgery, patient interaction
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Interaction GroupOther
Also called Control Group
No interventions or procedures will be applied to the patients. To evaluate whether the pain, anxiety, and comfort of patients undergoing the same surgical procedure are influenced by each other, the average scale scores of patients in double and single rooms will be compared.
| Study group | Role | What they receive |
|---|---|---|
| Patient Interaction Group | Patients who undergo the same surgical procedure on the same day and stay in the same room during the postoperative period will form this group. Receives: Other: Patient Interaction Group | |
| Control group | Patients who undergo the same surgical procedure on the same day and stay in a single room during the postoperative period will form this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Visual Analog Scale
Visual Analog Scale (VAS) is a standard scale used to assess the intensity of pain. Pain severity is represented by "No pain = 0" and "Worst pain = 10," and it is evaluated on a scale from 0 to 10.
Measured: Postoperative assessments will be carried out at 1, 4, 8, 12, 16, and 24 hours after surgery.
Change from State Anxiety Scale
Spielberger State-Trait Anxiety Inventory: The scale, developed by Spielberger in 1970, was validated in Turkish. The scale measures two dimensions of anxiety: State Anxiety and Trait Anxiety. The State Anxiety Scale consists of 20 items that describe how individuals feel at a specific moment under certain conditions, reflecting their emotions related to the situation they are in. The Trait Anxiety Scale consists of 20 items describing how individuals generally feel. In total, the scale includes 40 four-point Likert-type questions. The scale contains both direct and reverse-scored items. In the State Anxiety Scale, there are 10 reverse-scored items, and in the Trait Anxiety Scale, there are 7 reverse-scored items. The reverse-scored items in the State Anxiety Inventory are items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20. The reverse-scored items in the Trait Anxiety Inventory are items 21, 26, 27, 30, 33, 36, and 39.
Measured: Postoperative assessments will be carried out at 1, 8, and 24 hours after surgery.
Change from Trait Anxiety Scale
Spielberger State-Trait Anxiety Inventory: The scale, developed by Spielberger in 1970, was validated in Turkish. The scale measures two dimensions of anxiety: State Anxiety and Trait Anxiety. The State Anxiety Scale consists of 20 items that describe how individuals feel at a specific moment under certain conditions, reflecting their emotions related to the situation they are in. The Trait Anxiety Scale consists of 20 items describing how individuals generally feel. In total, the scale includes 40 four-point Likert-type questions. The scale contains both direct and reverse-scored items. In the State Anxiety Scale, there are 10 reverse-scored items, and in the Trait Anxiety Scale, there are 7 reverse-scored items. The reverse-scored items in the State Anxiety Inventory are items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20. The reverse-scored items in the Trait Anxiety Inventory are items 21, 26, 27, 30, 33, 36, and 39.
Measured: Inpatient admission
Change from Immobility Comfort Scale
The scale developed by Hogan-Miller in 1995 was validated for Turkish in a group of patients immobilized due to lower extremity surgery. The Immobility Comfort Scale (ICS) is a 20-item scale using Likert-type response options. Each statement in the questionnaire has a Likert-type response ranging from 1 to 6, from "strongly disagree" to "strongly agree." The positive and negative items are mixed in the questionnaire. For positive items, the highest score (6 points) indicates the highest level of comfort, while the lowest score (1 point) indicates the lowest level of comfort. To calculate the total score of the questionnaire, the scores for the negative items are reverse-coded and added to the scores for the positive items. The minimum and maximum total scores in the questionnaire are 20 and 120 points, respectively. The average item score ranges from 1 to 6 and is determined by dividing the total score by the number of items in the questionnaire.
Measured: Postoperative assessments will be carried out at 1, 8, and 24 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start15 Dec 2024 (estimated)
- Primary completion15 Mar 2025 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Ankara 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
- Other
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nursemin ÜNAL, Ankara University
- Investigators
- Nursemin Unal, Study director, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707597
- Sponsor's protocol ID
- AEŞH-BADEK-2024-773
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Andersson V, Bergstrand J, Engstrom A, Gustafsson S. The Impact of Preoperative Patient Anxiety on Postoperative Anxiety and Quality of Recovery After Orthopaedic Surgery. J Perianesth Nurs. 2020 Jun;35(3):260-264. doi: 10.1016/j.jopan.2019.11.008. Epub 2020 Mar 5.
PubMed 32147278Spielberger, C. D. (2010). State-trait anxiety inventory. In The Corsini Encyclopedia of Psychology (pp. 1-1). Wiley.
Öner, N, & LeCompte A. (1985). Durumluk-Sürekli Kaygı Envanteri El Kitabı. 2. Baskı. İstanbul: Boğaziçi üniversitesi Yayınları.
Tosun B, Aslan O, Tunay S, Akyuz A, Ozkan H, Bek D, Aciksoz S. Turkish Version of Kolcaba's Immobilization Comfort Questionnaire: A Validity and Reliability Study. Asian Nurs Res (Korean Soc Nurs Sci). 2015 Dec;9(4):278-84. doi: 10.1016/j.anr.2015.07.003. Epub 2015 Sep 16.
PubMed 26724235Caliskan E, Aksoy N. The Relationship Between Preoperative Anxiety Level and Postoperative Pain Outcomes in Total Hip and Knee Replacement Surgery: A Cross-sectional Study. J Perianesth Nurs. 2025 Feb;40(1):76-82. doi: 10.1016/j.jopan.2024.03.010. Epub 2024 Jul 8.
PubMed 38980235Xu JJ, Tang XT, Fu WC, Zheng JX, Jiang LP, Zhou YW, Yang QN. "Adjacent Bed Effect" of Total Knee Arthroplasty Patients During the Perioperative Period. Pain Manag Nurs. 2024 Feb;25(1):88-92. doi: 10.1016/j.pmn.2023.09.003. Epub 2023 Oct 20.
PubMed 37867077
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Interaction Among Patients on Pain, Anxiety, and Comfort After Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT06707597
- Acronym / sponsor ID
- AEŞH-BADEK-2024-773
- Keywords
- pain, anxiety, comfort, orthopedic surgery, patient interaction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 27 Nov 2024 (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 aims to evaluate the effects of interaction among patients on pain, anxiety, and comfort after orthopedic surgery.
Detailed description
Surgical procedures can cause pain and anxiety in patients, affecting their comfort levels. Orthopedic surgeries, in particular, are associated with high pain levels. For example, common orthopedic procedures like total knee and hip replacement can cause patients to experience severe pain on the first-day post-surgery. In modern surgical practices, pain management requires the combined use of both pharmacological and non-pharmacological methods. Additionally, various stressors in the hospital environment-such as the sounds of medical devices and monitors, and crowded hospital rooms-can create extra stress for orthopedic patients, especially those with limited mobility. Another important factor is the interaction among patients in the same environment. The presence of another patient in the same room can affect not only environmental comfort but also, through "emotional contagion," the patient's emotional state. Emotional contagion is defined as the transfer of emotions from one person to another, and this interaction can trigger patients' pain and anxiety levels. Particularly, patients who have undergone similar surgical experiences may share each other's emotions empathetically, thereby increasing pain and anxiety. This study aims to examine the effects of patient interaction in the same room on pain, anxiety, and comfort in orthopedic patients.
The study population will consist of patients who undergo lower and upper extremity surgeries in the orthopedics and traumatology clinic of a state hospital in Turkey. Patients who undergo the same surgical procedure on the same day and stay in the same room postoperatively, or those who are in single rooms, will form the study sample. To obtain reliable results, at least 128 patients will be required, with 64 patients in the group sharing a room and 64 patients in the single-room control group. The goal is to reach this sample size during the planning and implementation phases of the research. Considering a 10% patient dropout rate, 70 patients in the shared room group and 70 patients in the single room group, for a total of 140 patients, will be included in the study. Patients will be grouped according to lower and upper extremity surgeries, and pairs will be formed for placement in the same rooms. Patients discharged within 24 hours will be evaluated during their hospital stay. Additionally, a control group of patients in single rooms will be included to assess the impact of staying in the same room.
Before surgery, the patients' trait anxiety levels will be measured using the State-Trait Anxiety Inventory. After the surgery, once patients are placed in their rooms, pain will be assessed at 1, 4, 8, 12, 16, and 24 hours using the Visual Analog Scale for pain at the surgical site, back, and head/neck. Also, at 1, 8, and 24 hours, their state anxiety and immobilization comfort will be evaluated.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Interaction Group | – | Other: Patient Interaction GroupPatients who undergo the same surgical procedure on the same day and stay in the same room during the postoperative period will form this group. |
| Control group | – | –Patients who undergo the same surgical procedure on the same day and stay in a single room during the postoperative period will form this group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of all adult patients who have undergone lower and upper extremity surgery at the relevant state hospital during the study period, meet the inclusion criteria, and voluntarily agree to participate in the study.
Key inclusion criteria (4 listed)
- To have undergone lower and upper extremity surgery at a state hospital,
- To be over 18 years of age,
- To stay in the hospital for at least one night,
- To agree to participate in the study.
Key exclusion criteria (4 listed)
- Patients who undergo emergency surgical procedures,
- Patients with language barriers, learning difficulties, or cognitive diseases such as dementia that prevent them from completing the questionnaires,
- Patients with epidural or other catheters,
- Patients who do not wish to participate in the study will be excluded from the research.
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 |
|---|---|---|
| Patient Interaction GroupAlso: Control GroupNo interventions or procedures will be applied to the patients. To evaluate whether the pain, anxiety, and comfort of patients undergoing the same surgical procedure are influenced by each other, the average scale scores of patients in double and single rooms will be compared. | Other | Patient Interaction Group |
Primary outcome
Change from Visual Analog Scale
Time frame: Postoperative assessments will be carried out at 1, 4, 8, 12, 16, and 24 hours after surgery.
Visual Analog Scale (VAS) is a standard scale used to assess the intensity of pain. Pain severity is represented by "No pain = 0" and "Worst pain = 10," and it is evaluated on a scale from 0 to 10.
Change from State Anxiety Scale
Time frame: Postoperative assessments will be carried out at 1, 8, and 24 hours after surgery.
Spielberger State-Trait Anxiety Inventory: The scale, developed by Spielberger in 1970, was validated in Turkish. The scale measures two dimensions of anxiety: State Anxiety and Trait Anxiety. The State Anxiety Scale consists of 20 items that describe how individuals feel at a specific moment under certain conditions, reflecting their emotions related to the situation they are in. The Trait Anxiety Scale consists of 20 items describing how individuals generally feel. In total, the scale includes 40 four-point Likert-type questions. The scale contains both direct and reverse-scored items. In the State Anxiety Scale, there are 10 reverse-scored items, and in the Trait Anxiety Scale, there are 7 reverse-scored items. The reverse-scored items in the State Anxiety Inventory are items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20. The reverse-scored items in the Trait Anxiety Inventory are items 21, 26, 27, 30, 33, 36, and 39.
Change from Trait Anxiety Scale
Time frame: Inpatient admission
Spielberger State-Trait Anxiety Inventory: The scale, developed by Spielberger in 1970, was validated in Turkish. The scale measures two dimensions of anxiety: State Anxiety and Trait Anxiety. The State Anxiety Scale consists of 20 items that describe how individuals feel at a specific moment under certain conditions, reflecting their emotions related to the situation they are in. The Trait Anxiety Scale consists of 20 items describing how individuals generally feel. In total, the scale includes 40 four-point Likert-type questions. The scale contains both direct and reverse-scored items. In the State Anxiety Scale, there are 10 reverse-scored items, and in the Trait Anxiety Scale, there are 7 reverse-scored items. The reverse-scored items in the State Anxiety Inventory are items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20. The reverse-scored items in the Trait Anxiety Inventory are items 21, 26, 27, 30, 33, 36, and 39.
Change from Immobility Comfort Scale
Time frame: Postoperative assessments will be carried out at 1, 8, and 24 hours after surgery.
The scale developed by Hogan-Miller in 1995 was validated for Turkish in a group of patients immobilized due to lower extremity surgery. The Immobility Comfort Scale (ICS) is a 20-item scale using Likert-type response options. Each statement in the questionnaire has a Likert-type response ranging from 1 to 6, from "strongly disagree" to "strongly agree." The positive and negative items are mixed in the questionnaire. For positive items, the highest score (6 points) indicates the highest level of comfort, while the lowest score (1 point) indicates the lowest level of comfort. To calculate the total score of the questionnaire, the scores for the negative items are reverse-coded and added to the scores for the positive items. The minimum and maximum total scores in the questionnaire are 20 and 120 points, respectively. The average item score ranges from 1 to 6 and is determined by dividing the total score by the number of items in the questionnaire.
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 29 Nov 2024.
- Background: PubMed 32147278Andersson V, Bergstrand J, Engstrom A, Gustafsson S. The Impact of Preoperative Patient Anxiety on Postoperative Anxiety and Quality of Recovery After Orthopaedic Surgery. J Perianesth Nurs. 2020 Jun;35(3):260-264. doi: 10.1016/j.jopan.2019.11.008. Epub 2020 Mar 5.
- BackgroundSpielberger, C. D. (2010). State-trait anxiety inventory. In The Corsini Encyclopedia of Psychology (pp. 1-1). Wiley.
- BackgroundÖner, N, & LeCompte A. (1985). Durumluk-Sürekli Kaygı Envanteri El Kitabı. 2. Baskı. İstanbul: Boğaziçi üniversitesi Yayınları.
- Results publication: PubMed 26724235Tosun B, Aslan O, Tunay S, Akyuz A, Ozkan H, Bek D, Aciksoz S. Turkish Version of Kolcaba's Immobilization Comfort Questionnaire: A Validity and Reliability Study. Asian Nurs Res (Korean Soc Nurs Sci). 2015 Dec;9(4):278-84. doi: 10.1016/j.anr.2015.07.003. Epub 2015 Sep 16.
- Results publication: PubMed 38980235Caliskan E, Aksoy N. The Relationship Between Preoperative Anxiety Level and Postoperative Pain Outcomes in Total Hip and Knee Replacement Surgery: A Cross-sectional Study. J Perianesth Nurs. 2025 Feb;40(1):76-82. doi: 10.1016/j.jopan.2024.03.010. Epub 2024 Jul 8.
- Results publication: PubMed 37867077Xu JJ, Tang XT, Fu WC, Zheng JX, Jiang LP, Zhou YW, Yang QN. "Adjacent Bed Effect" of Total Knee Arthroplasty Patients During the Perioperative Period. Pain Manag Nurs. 2024 Feb;25(1):88-92. doi: 10.1016/j.pmn.2023.09.003. Epub 2023 Oct 20.
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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.
Nursemin Unal study director
Ankara University
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Anxiety, run by Ankara 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 4 inclusion and 4 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 29 Nov 2024. 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 Nursemin Unal (+905077433629, nurse_unal@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Visual Analog Scale (time frame: Postoperative assessments will be carried out at 1, 4, 8, 12, 16, and 24 hours after surgery.). The study lists 4 primary outcomes in all. 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 NCT06707597, which also lists 6 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 29 Nov 2024.