AnxietyNCT06723600
Effect of Informing Family Members of Patients During Surgery
A study testing Information in people with Anxiety, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2024to 10 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Karadeniz Technical University
Trabzon, Milli Egemenlik, 61080
Bahar Candas Altinbas, PhD, +90 545 9125343, baharcandas@ktu.edu.tr
About this study
Official title: 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.
Read the 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.
- Conditions
- Anxiety
- Being tested
- Information
- Keywords
- Anxiety, Informing, Relatives of the Patient, Phone Call, Satisfaction
- Medical subject headings
- Anxiety Disorders, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InformationOther
Nurse-led family member information
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The experimental group relatives of patients will be informed by the nurse during surgery. Receives: Other: Information |
| Control Group | No intervention | The control group will take rutin informing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During surgery
Secondary outcomes (1)
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.
Measured: Immediately after the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start10 Jun 2024
- Primary completion10 Feb 2025 (estimated)
- Study completion10 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahar CANDAS ALTINBAS, Karadeniz Technical University
- Investigators
- Bahar Candas Altinbas, Principal investigator, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723600
- Sponsor's protocol ID
- Nurse_Anxiety
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Informing Family Members of Patients by Phone Call on Their Anxiety Level During Undergoing Abdominal Cancer Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06723600
- Acronym / sponsor ID
- Nurse_Anxiety
- Conditions
- Anxiety
- Keywords
- Anxiety, Informing, Relatives of the Patient, Phone Call, Satisfaction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 10 Feb 2025 (estimated)
- Study completion
- 10 May 2025 (estimated)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: InformationThe experimental group relatives of patients will be informed by the nurse during surgery. |
| Control Group | No intervention | –The control group will take rutin informing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (5 listed)
- Having a hearing or speech impairment,
- Having a psychiatric disorder or using psychiatric medication.
- Inability to reach the participant when called during the surgery,
- The patient's death during the surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InformationNurse-led family member information | Other | Experimental Group |
Primary outcome
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.
1 secondary outcome
Satisfaction with Telephone Information Provided During Surgery
Time frame: Immediately after the surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bahar Candas Altinbas principal investigator
Karadeniz Technical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Information in people with Anxiety, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bahar Candas Altinbas, PhD (+90 545 912 5343, baharcandas@ktu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.