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

November 26, 2024 updated by: Nursemin ÜNAL, Ankara University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: 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.
Other Names:
  • Control 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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Postoperative assessments will be carried out at 1, 4, 8, 12, 16, and 24 hours after surgery.
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.
Postoperative assessments will be carried out at 1, 8, and 24 hours after surgery.
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.
Inpatient admission
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.
Postoperative assessments will be carried out at 1, 8, and 24 hours after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Investigators

  • Study Director: Nursemin Unal, Ankara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 15, 2024

Primary Completion (Estimated)

March 15, 2025

Study Completion (Estimated)

March 15, 2025

Study Registration Dates

First Submitted

November 25, 2024

First Submitted That Met QC Criteria

November 25, 2024

First Posted (Actual)

November 27, 2024

Study Record Updates

Last Update Posted (Actual)

November 29, 2024

Last Update Submitted That Met QC Criteria

November 26, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEŞH-BADEK-2024-773

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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