Effect of Informing Family Members of Patients During Surgery

Effect of Informing Family Members of Patients by Phone Call on Their Anxiety Level During Undergoing Abdominal Cancer Surgery: A Randomized Controlled Trial

Psychological and physiological issues encountered by family members due to the intraoperative process are factors that complicate the support and care systems of the patient. It is stated that family members of patients undergoing surgery, especially those who do not have sufficient information about the surgical process, experience stress, anxiety, and concern. The need for nursing interventions aimed at providing information about the surgical process, reducing the anxiety levels of family members during the surgery, and supporting them is emphasized. In this context, the study aims to evaluate the effect of periodically informing family members of patients undergoing abdominal cancer surgery via phone during the surgery on their anxiety levels.

Study Overview

• Status: Recruiting
• Conditions: Anxiety
• Intervention / Treatment: Other: Information

Detailed Description

Once the patient scheduled for surgery is taken to the operating room, communication between the family members and the surgical team, as well as the patient, is cut off. Family members who do not have any information about the progress of the surgery experience anxiety during the waiting period. High levels of anxiety can limit the family members' ability to understand and process information, affecting their ability to cope with the situation. The high anxiety experienced by family members during the surgery can reflect onto the patient postoperatively, potentially negatively impacting the patient's adaptation, recovery process, and family relations. It is known that family members of patients undergoing cancer surgery experience a higher level of anxiety. The anxiety emerging during this process leads to various physiological and psychological negative consequences for the family members. It is known that informing family members by nurses during surgery helps reduce their anxiety. In this direction, the primary aim of the study is to determine the effect of periodically informing family members of patients undergoing abdominal cancer surgery via phone during the surgery on their anxiety levels. Additionally, the study will evaluate the satisfaction levels of the participants.

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bahar Candas Altinbas, PhD; Phone Number: +90 545 912 5343; Email: baharcandas@ktu.edu.tr
• Study Contact Backup: Name: Zeynep Cayirezmez; Phone Number: +90 5418911775; Email: zeynep_cayirezmez@hotmail.com

Study Locations

• Turkey
  • Milli Egemenlik
    • Trabzon, Milli Egemenlik, Turkey, 61080
      • Recruiting
      • Karadeniz Technical University
      • Contact: Bahar Candas Altinbas, PhD; Phone Number: +90 545 9125343; Email: baharcandas@ktu.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Being a first-degree relative who has given consent,
• Being able to understand and speak Turkish,
• Being literate,
• Willing to participate in the study,
• Using a phone,
• Being present in the hospital before, during, and after the surgery.

Exclusion Criteria:

• Having a hearing or speech impairment,
• Having a psychiatric disorder or using psychiatric medication.

Endpoint Criteria:

• Inability to reach the participant when called during the surgery,
• The patient's death during the surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; The experimental group relatives of patients will be informed by the nurse during surgery.	Other: Information; Nurse-led family member information
No Intervention: Control Group; The control group will take rutin informing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	The patient's anxiety level 2 hours after the start of the surgical procedure. Self reported anxiety intensity before surgical process that includes on the day of surgery. State-Trait Anxiety Inventory will be used to evaluate the anxiety. The higher the score is the more anxiety.	During surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with Telephone Information Provided During Surgery	The satisfaction levels of family members in the experimental group with the information provided through telephone calls during the surgery will be assessed using the "Evaluation Form for Telephone Information During Surgery," developed by the researcher based on the literature and validated for content.	Immediately after the surgery.

Collaborators and Investigators

• Sponsor: Karadeniz Technical University
• Investigators: Principal Investigator: Bahar Candas Altinbas, Karadeniz Technical University

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2024
• Primary Completion (Estimated): February 10, 2025
• Study Completion (Estimated): May 10, 2025

Study Registration Dates

• First Submitted: December 2, 2024
• First Submitted That Met QC Criteria: December 4, 2024
• First Posted (Estimated): December 9, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Anxiety; Satisfaction; Phone Call; Informing; Relatives of the Patient
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: Nurse_Anxiety

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No