Patient Interaction Effects on Pain, Anxiety, and Comfort After Orthopedic Surgery

NCT ID: NCT06707597

Last Updated: 2024-11-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-12-15
• Study Completion Date: 2025-03-15

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.

Conditions

Pain; Anxiety; Surgery

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Patient Interaction Group

Intervention Type: OTHER

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.

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.

No interventions assigned to this group

Interventions

Patient Interaction 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.

Intervention Type: OTHER

Other Intervention Names

Control Group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ankara University

OTHER

Sponsor Role: lead

Responsible Party

Nursemin ÜNAL

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nursemin Unal

Role: STUDY_DIRECTOR

Ankara University

Central Contacts

Nursemin Unal

Role: CONTACT

nurse_unal@hotmail.com

+905077433629

References

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.

Reference Type: BACKGROUND

PMID: 32147278 (View on PubMed)

Spielberger, C. D. (2010). State-trait anxiety inventory. In The Corsini Encyclopedia of Psychology (pp. 1-1). Wiley.

Reference Type: BACKGROUND

Öner, N, & LeCompte A. (1985). Durumluk-Sürekli Kaygı Envanteri El Kitabı. 2. Baskı. İstanbul: Boğaziçi üniversitesi Yayınları.

Reference Type: BACKGROUND

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.

Reference Type: RESULT

PMID: 26724235 (View on PubMed)

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.

Reference Type: RESULT

PMID: 38980235 (View on PubMed)

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.

Reference Type: RESULT

PMID: 37867077 (View on PubMed)

Other Identifiers

AEŞH-BADEK-2024-773

Identifier Type: -

Identifier Source: org_study_id