Effects of Preparatory Information on Anxiety and Treatment Adherence in Heart Surgery Patients
NCT ID: NCT06201117
Last Updated: 2024-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
48 participants
INTERVENTIONAL
2023-12-27
2024-09-30
Brief Summary
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* Are the anxiety levels before and after receiving prepared information video (VDO) and usual information different among participants in the experimental group?
* Are the anxiety levels between participants who received prepared information VDO and usual information and usual information only different?
* Are the cooperative behaviors during a recovery period in the ICU between participants who received prepared information VDO and usual information and usual information only different?
The researcher will provide the prepared information for ICU stay through 12-minutes VDO, 2 times before the surgery to the experimental group in addition to the usual pre-operative information (usual care). Participants in the comparison group will receive usual pre-operative information only to see if the anxiety and cooperative behaviors during a recovery period in the ICU differ between the groups.
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Detailed Description
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Additionally, the invitation will also be posted at the in-patient facilities where patients are being admitted for heart surgery so the nurses to ask patients for their interest in being the study volunteers. The researchers will be notified if there are potential participants.
* Recruitment and consent process The researcher will meet with prospective participants in in-patient units where they are being admitted for surgery to discuss the study details and evaluate the Abbreviated Mental Test for screening. Potential participants who have an AMT test score of less than 8 will be excluded and thanked for their volunteer. The consent will be signed by the patients who agree to participate. The meeting will take place between 6:00 and 8:00 p.m. after patients have completed all preoperative preparations and have had dinner.
* Research assistants Two research assistants in this study are registered nurses with more than 3 years of experience in caring for heart surgery patients. They were trained to follow the study protocol and use research instruments. The interrater reliability between the researchers and research assistants is 0.96. To avoid bias, the research assistants will evaluate the outcomes in both the experimental and comparison groups while remaining blind to group allocation.
* Sample size estimation The sample size estimation was calculated using the G\*Power 3.1.9.7 program for a two-sample t-test for independent with 0.8 effect size from Cohen's d formula (Cohen, 1988) using mean anxiety from a similar study. The estimated sample size needed for this study is 21 for each group with 10% adjusted for attrition resulting in 24 participants necessary for each group to demonstrate an effect.
* Data collection Data collection starts once the participants sign the consent. The participants will be allocated to a group with computer computer-generated program. Allocation to the group cannot be concealed from the participants but will be blinded to the research assistants who evaluate the outcomes. In the experimental group, the researcher asks participants to rate their anxiety before receiving the intervention (12-minute preparation information video + usual preparation information) while in the comparison group, only usual preparation information is given. The participants rated their anxiety again 30 minutes after the intervention and the usual information was given. The experimental group will receive the preparation VDO again the day before surgery. Participants in both groups rate their anxiety 48 hours after surgery and are evaluated for treatment adherence during their ICU stay. Participants who are unable to participate until the completion of the trial for any reason will be withdrawn from the study and analysis. Individual participant identities will not be recorded or disclosed in any way. Data analysis will be used to identify groups, and all recorded information will be deleted two years after the study is completed.
* Data analysis The data analysis will be performed using the Statistical Package for the Social Sciences (SPSS) version 28 software with a confidence interval of 95% (α=0.05). Descriptive statistics, Chi-square test, ANOVA, and Mann-Whitney U test will be analyzed to evaluate demographic differences between the groups depending on the normality assumption. Repeated measures ANOVA and ANCOVA will be used to analyze differences in anxiety and treatment adherence within the groups and between the groups, respectively. However, if the normality assumption is not fulfilled, the Mann-Whitney U test and Chi-square will be performed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Preparatory information
In the experimental group, the participants will rate their anxiety before receiving the 12-minute preparation information video in addition to the usual preparation information on the day they gave consent to participate in the study. The participants will rate their anxiety again 30 minutes after the intervention. The experimental group will receive the preparation video again the second time on the day before surgery. Anxiety and treatment adherence will be measured in the ICU, 48 hours after the surgery.
Preparatory information for ICU stay
Preparatory information for ICU stay after cardiac surgery via 12-minute digital media
Usual information
Preoperative information that is given to patients before having cardiac surgery
Usual information
In the comparison group, the participants will rate their anxiety before receiving the usual preoperative information on the day they gave consent to participate in the study. The participants will rate their anxiety again 30 minutes after the usual information. Anxiety and treatment adherence will be measured in the ICU, 48 hours after the surgery.
Usual information
Preoperative information that is given to patients before having cardiac surgery
Interventions
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Preparatory information for ICU stay
Preparatory information for ICU stay after cardiac surgery via 12-minute digital media
Usual information
Preoperative information that is given to patients before having cardiac surgery
Eligibility Criteria
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Inclusion Criteria
2. Never been admitted to the intensive care unit.
3. Stable condition before surgery
4. Ability to understand communication in Thai
5. Willingness to participate in the study.
Exclusion Criteria
2. Admitted to the hospital in an emergency and need urgent surgery.
18 Years
ALL
No
Sponsors
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Khon Kaen University
OTHER
Responsible Party
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Keattiwan Kansaard
Faculty of Nursing
Principal Investigators
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Dr.RACHATA MALA, 3
Role: STUDY_CHAIR
Faculty of medicine, KKU
Locations
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Srinagarind Hospital, Khon Kean University
Khon Kaen, , Thailand
Countries
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Central Contacts
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Associate Prof.Dr. WASANA RUAISUNGNOEN, 2
Role: CONTACT
Facility Contacts
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References
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Aardoom JJ, Loheide-Niesmann L, Ossebaard HC, Riper H. Effectiveness of eHealth Interventions in Improving Treatment Adherence for Adults With Obstructive Sleep Apnea: Meta-Analytic Review. J Med Internet Res. 2020 Feb 18;22(2):e16972. doi: 10.2196/16972.
Aust H, Eberhart L, Sturm T, Schuster M, Nestoriuc Y, Brehm F, Rusch D. A cross-sectional study on preoperative anxiety in adults. J Psychosom Res. 2018 Aug;111:133-139. doi: 10.1016/j.jpsychores.2018.05.012. Epub 2018 May 22.
Bowyer A, Jakobsson J, Ljungqvist O, Royse C. A review of the scope and measurement of postoperative quality of recovery. Anaesthesia. 2014 Nov;69(11):1266-78. doi: 10.1111/anae.12730. Epub 2014 Jun 2.
Cardiovascular thoracic intensive care unit. (2020). Srinagarind hospital adult cardiac surgery database: 2020 update.
Dale JG, Midthus E, Dale B. Using information and communication technology in the recovery after a coronary artery bypass graft surgery: patients' attitudes. J Multidiscip Healthc. 2018 Aug 30;11:417-423. doi: 10.2147/JMDH.S175195. eCollection 2018.
Elgazzar SE, Qalawa SAA, Ali Hassan AM. Impact of educational programme on patient's health outcomes following open heart surgeries. Nurs Open. 2023 May;10(5):3028-3041. doi: 10.1002/nop2.1549. Epub 2022 Dec 8.
Other Identifiers
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HE661478
Identifier Type: -
Identifier Source: org_study_id
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