Clinical trial NCT06707597: Patient Interaction Effects on Pain, Anxiety, and Comfort After Orthopedic Surgery
Official title: The Effects of Interaction Among Patients on Pain, Anxiety, and Comfort After Orthopedic Surgery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pain
Anxiety
Surgery
Keywords: pain
anxiety
comfort
orthopedic surgery
patient interaction
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from Visual Analog Scale
timeFrame: Postoperative assessments will be carried out at 1, 4, 8, 12, 16, and 24 hours after surgery.
measure: Change from State Anxiety Scale
timeFrame: Postoperative assessments will be carried out at 1, 8, and 24 hours after surgery.
measure: Change from Trait Anxiety Scale
timeFrame: Inpatient admission
measure: Change from Immobility Comfort Scale
timeFrame: Postoperative assessments will be carried out at 1, 8, and 24 hours after surgery.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ankara University
name: Nursemin Unal
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Spielberger, C. D. (2010). State-trait anxiety inventory. In The Corsini Encyclopedia of Psychology (pp. 1-1). Wiley.
citation: Öner, N, & LeCompte A. (1985). Durumluk-Sürekli Kaygı Envanteri El Kitabı. 2. Baskı. İstanbul: Boğaziçi üniversitesi Yayınları.
citation: 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.
citation: Caliskan 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.
citation: Xu 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.