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NCT Number: NCT06723600

Effect of Informing Family Members of Patients During Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karadeniz Technical University

Trabzon, Milli Egemenlik, 61080, Turkey (Türkiye)

Location status: Recruiting

Location contact

Bahar Candas Altinbas, PhD

CONTACT

[email protected]

+90 545 9125343

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Information

Other

Nurse-led family member information

Primary outcomes

  1. Anxiety

    Time frame: During surgery

    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.

Secondary outcomes

  1. Satisfaction with Telephone Information Provided During Surgery

    Time frame: Immediately after the 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bahar Candas Altinbas, PhD

CONTACT

[email protected]

+90 545 912 5343

Zeynep Cayirezmez

CONTACT

[email protected]

+90 5418911775

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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