Heart SurgeryNCT06201117
Effects of Preparatory Information on Anxiety and Treatment Adherence in Heart Surgery Patients
A study testing Preparatory information for ICU stay and Usual information in people with Heart Surgery, run by Khon Kaen University at 1 site in Thailand.
Trial summary
The goal of this clinical trial is to investigate the effects of providing information to prepare for ICU stay in patients after heart surgery on anxiety and cooperative behaviors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Surgery
- What is being tested?
- Preparatory information for ICU stay and Usual information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteThailand
- Study dates
- 27 Dec 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Attending heart surgery as scheduled for the first time
- Never been admitted to the intensive care unit.
- Stable condition before surgery
- Ability to understand communication in Thai
- Willingness to participate in the study.
Who cannot join
- Impaired cognitive ability: assessed by the Abbreviated Mental Test (AMT) when the score is less than 8 out of 10.
- Admitted to the hospital in an emergency and need urgent surgery.
Trial locations and contacts
1 site in 1 country.
Associate Prof.Dr. WASANA RUAISUNGNOEN, 2 contact
Thailand1 site, 1 recruiting
- Recruiting
Srinagarind Hospital, Khon Kean University
Khon Kaen, 40002
Miss KEATTIWAN KANSAARD, 1, 66930537055, keattiwan.k@kkumail.com
Associate Prof. Dr. WASANA RUAISUNGNOEN, 2, 66885525665, waskir@kku.ac.th
About this study
Official title: The Effects of Preparatory Information Using Digital Media on Anxiety and Treatment Adherence Behavior in Patients Undergoing Cardiac Surgery
The goal of this clinical trial is to investigate the effects of providing information to prepare for ICU stay in patients after heart surgery on anxiety and cooperative behaviors. The main questions it aims to answer are:
- 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.
Read the detailed description
- Participant invitation The study invitation for the prospective participants who are patients scheduled for heart surgery is posted at the cardiothoracic surgery outpatient clinic. Before deciding, patients who are interested in participating can get in touch with the researchers to learn more about the study.
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
- Heart Surgery
- Being tested
- Preparatory information for ICU stay, Usual information
- Keywords
- Heart Surgery, Digital Media, Preparatory Information
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preparatory information for ICU stayBehavioural
Preparatory information for ICU stay after cardiac surgery via 12-minute digital media
Usual informationBehavioural
Preoperative information that is given to patients before having cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| Preparatory information | Experimental | 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. Receives: Behavioral: Preparatory information for ICU stay; Behavioral: Usual information |
| Usual information | Active comparator | 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. Receives: Behavioral: Usual information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
The 1-Item Anxiety Visual Analogue Scale (AVAS) horizontal version is used to assess participants' level of perceived anxiety. AVAS is a numerical scale that is rated on a 10-centimeter linear scale, with 0 indicating no anxiety on the left end and 10 reflecting the most intense anxiety, representing a score of 100 on the right end.
Measured: Anxiety will be measured 3 times in both groups immediately before receiving preparatory information or usual information, 30 minutes after receiving preparatory information or usual information, and 48 hours after the surgery.
Treatment adherence
Treatment adherence is measured using the observational checklist developed by the researchers based on the content instructed in the preparatory information VDO. The checklist consists of 19 items in 4 categories including procedural adherence, sensory adherence, behavioral adherence, and coping adherence The checklist was evaluated by 5 experts and yielded a scale content validity index (S-CVI) of 1.0. The score of each item is rated as 0-2 scale where 0 means no adherence, 1 is partial adherence, and 2 is absolute adherence. The total possible score ranges from 0-57.
Measured: The research assistants who are blinded for the participant groups evaluate the treatment adherence 1 time at 48 hours 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 posted11 Jan 2024
- Study start27 Dec 2023
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Heart SurgeryStudies 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
- Model description
- 2-arm parallel randomized controlled trial study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keattiwan Kansaard, Khon Kaen University
- Investigators
- Dr.RACHATA MALA, 3, Study chair, Faculty of medicine, KKU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201117
- Sponsor's protocol ID
- HE661478
- Status last verified
- Jan 2024
- First submitted
- 31 Dec 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32130137Aust 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.
PubMed 29935747Bowyer 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.
PubMed 24888412Cardiovascular 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.
PubMed 30214223Elgazzar 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.
PubMed 36480022
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Preparatory Information Using Digital Media on Anxiety and Treatment Adherence Behavior in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06201117
- Acronym / sponsor ID
- HE661478
- Conditions
- Heart Surgery
- Keywords
- Heart Surgery, Digital Media, Preparatory Information
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 11 Jan 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.
The goal of this clinical trial is to investigate the effects of providing information to prepare for ICU stay in patients after heart surgery on anxiety and cooperative behaviors. The main questions it aims to answer are:
- 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.
Detailed description
- Participant invitation The study invitation for the prospective participants who are patients scheduled for heart surgery is posted at the cardiothoracic surgery outpatient clinic. Before deciding, patients who are interested in participating can get in touch with the researchers to learn more about the study.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 2-arm parallel randomized controlled trial study
| Arm | Type | Receives |
|---|---|---|
| Preparatory information | Experimental | Behavioral: Preparatory information for ICU stay, Behavioral: Usual informationIn 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. |
| Usual information | Active comparator | Behavioral: Usual informationIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Attending heart surgery as scheduled for the first time
- Never been admitted to the intensive care unit.
- Stable condition before surgery
- Ability to understand communication in Thai
- Willingness to participate in the study.
Key exclusion criteria (2 listed)
- Impaired cognitive ability: assessed by the Abbreviated Mental Test (AMT) when the score is less than 8 out of 10.
- Admitted to the hospital in an emergency and need urgent 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 |
|---|---|---|
| Preparatory information for ICU stayPreparatory information for ICU stay after cardiac surgery via 12-minute digital media | Behavioural | Preparatory information |
| Usual informationPreoperative information that is given to patients before having cardiac surgery | Behavioural | Preparatory information, Usual information |
Primary outcome
Anxiety
Time frame: Anxiety will be measured 3 times in both groups immediately before receiving preparatory information or usual information, 30 minutes after receiving preparatory information or usual information, and 48 hours after the surgery.
The 1-Item Anxiety Visual Analogue Scale (AVAS) horizontal version is used to assess participants' level of perceived anxiety. AVAS is a numerical scale that is rated on a 10-centimeter linear scale, with 0 indicating no anxiety on the left end and 10 reflecting the most intense anxiety, representing a score of 100 on the right end.
Treatment adherence
Time frame: The research assistants who are blinded for the participant groups evaluate the treatment adherence 1 time at 48 hours after the surgery.
Treatment adherence is measured using the observational checklist developed by the researchers based on the content instructed in the preparatory information VDO. The checklist consists of 19 items in 4 categories including procedural adherence, sensory adherence, behavioral adherence, and coping adherence The checklist was evaluated by 5 experts and yielded a scale content validity index (S-CVI) of 1.0. The score of each item is rated as 0-2 scale where 0 means no adherence, 1 is partial adherence, and 2 is absolute adherence. The total possible score ranges from 0-57.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Results publication: PubMed 32130137Aardoom 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.
- Results publication: PubMed 29935747Aust 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.
- Results publication: PubMed 24888412Bowyer 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.
- Results publicationCardiovascular thoracic intensive care unit. (2020). Srinagarind hospital adult cardiac surgery database: 2020 update.
- Results publication: PubMed 30214223Dale 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.
- Results publication: PubMed 36480022Elgazzar 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.
- 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. This study is not recruiting at the moment.
Associate Prof.Dr. WASANA RUAISUNGNOEN, 2 contact
Dr.RACHATA MALA, 3 study chair
Faculty of medicine, KKU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preparatory information for ICU stay and Usual information in people with Heart Surgery, run by Khon Kaen University at 1 site in Thailand.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 12 Jan 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 Thailand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miss KEATTIWAN KANSAARD, 1 (66930537055, keattiwan.k@kkumail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: Anxiety will be measured 3 times in both groups immediately before receiving preparatory information or usual information, 30 minutes after receiving preparatory information or usual information, and 48 hours after the surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06201117, which also lists 6 linked publications.
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 12 Jan 2024.