Effect of Informing Family Members of Patients During Surgery

NCT06723600 | Recruiting

• 1 other identifier: Nurse_Anxiety
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety

Keywords

Anxiety; Informing; Relatives of the Patient; Phone Call; Satisfaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Satisfaction with Telephone Information Provided During Surgery

  Immediately after the surgery.

Study Arms (2)

Experimental Group

EXPERIMENTAL

The experimental group relatives of patients will be informed by the nurse during surgery.

Other: Information

Control Group

NO INTERVENTION

The control group will take rutin informing.

Interventions

Information OTHER

Nurse-led family member information

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Karadeniz Technical University

Trabzon, Milli Egemenlik, 61080, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Personal Satisfaction

Condition Hierarchy (Ancestors)

Mental Disorders; Behavior

Study Officials

• Bahar Candas Altinbas

  Karadeniz Technical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bahar Candas Altinbas, PhD

CONTACT

+90 545 912 5343; baharcandas@ktu.edu.tr

Zeynep Cayirezmez

CONTACT

+90 5418911775; zeynep_cayirezmez@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 9, 2024
• Study Start: June 10, 2024
• Primary Completion: February 10, 2025
• Study Completion: May 10, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)