SurgeryNCT05487430
Self-Affirmation for Managing Anxiety and Perceived Discomfort in Open-Heart Surgery
A study testing Positive Self-Affirmation in people with Surgery and Cardiac Disease, run by University of Vic - Central University of Catalonia at 1 site in Turkey (Türkiye).
Trial summary
This study adopted a randomized controlled pretest-posttest follow-up research design. The study was conducted at a public training and research hospital (Istanbul, Turkey) specialized in thoracic and cardiovascular surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Cardiac Disease
- What is being tested?
- Positive Self-Affirmation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jul 2019to 20 Mar 2020
- 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
- undergoing coronary artery bypass surgery for the first time,
- not having any history of a previous open cardiothoracic surgery
- being over 18 years
- being literate in Turkish.
Who cannot join
- having a diagnosed anxiety disorder
- having hearing deficiency
- having an emergency coronary artery bypass surgery
- staying in the cardiac intensive care unit for more than 48-hours
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mehmet Akif Ersoy Thoracic and Cardiovacular Surgery Training and Research Hospital
Istanbul, 34290
About this study
Official title: The Effect of Self-Affirmation on Anxiety and Perceived Discomfort in Patients Who Underwent Open-Heart Surgery. A Randomized Controlled Trial
This study adopted a randomized controlled pretest-posttest follow-up research design. The study was conducted at a public training and research hospital (Istanbul, Turkey) specialized in thoracic and cardiovascular surgery. The sample consisted of 61 patients randomized into two groups: intervention (n=34) and control (n=27). The participants of the intervention group listened to a self-affirmation audio recording for three days after surgery. Anxiety levels and perceived discomfort regarding pain, dyspnoea, palpitations, fatigue and nausea were measured daily. The study's main question is How do self-affirmation affect postoperative anxiety and perceived discomfort (regarding pain, dyspnoea, palpitations, fatigue and nausea) in patients who undergo open-heart surgery? In accordance with this question, the hypotheses was that repetitive positive self-affirmations decrease both anxiety and perceived discomfort in patients who underwent open-heart surgery.
Read the detailed description
This study adopted a randomized controlled pretest-posttest follow-up research design in accordance with CONSORT guidelines with 2 study groups (intervention and control).
The study was conducted among the patients who underwent open-heart surgery in the in-patient clinics of a public hospital (Istanbul, Turkey). Following the surgical intervention, all patients were admitted to the cardiac intensive care unit (CICU) for close postoperative follow-up. According to the hospital protocol, the minimum duration for a CICU stay is 2 days after surgery in patients that are hemodynamically stabilized. On their 3rd postoperative day, they are discharged from CICU to be admitted to the in-patient clinic and; in this study, their first day in the clinic was considered as the adaptation and resting period, so that the sampling process was started on the 4th postoperative day.
Eighty-five patients were assessed for eligibility. Five patients excluded from the study before randomization. Following the randomization, 12 patients were excluded during the initial allocation and then 7 more patients were excluded during the follow-up. The final study sample consisted of 61 patients who underwent CABS; 34 in the intervention group and 27 in the control group.
The baseline data (pre-test) was obtained on the fourth postoperative day considering the fact that the patients were comfortably adapted to the in-patient clinic and were more open to collaborate in the study. Additionally, preoperative anxiety weren't considered as a baseline evaluation because it is known that during the preoperative period the sources of anxiety are mainly related to uncertainties and fear of death, however during the postoperative period the patients are more likely to be concerned about their need to be protected, in other words, their vulnerability and fragility.
Each patient was followed up for 3 days. The data collection process was lasted 4 months, between the 20th of November of 2019 and the 20th of March of 2020.
In this study, intention-to-treat analysis was not used as all the participants were asked to listen to the self-affirmation recording at least once a day, because daily repetition is the key element when affirming positive sentences in order to mobilize the inner sources of the individual. Therefore, only per-protocol analysis where all participants strictly adhered to the study protocol was conducted.
The data were analysed by using the Statistical Package for the Social Sciences (IBM, SPSS, 21.0) at a significance level of 0.05. In the descriptive analysis, mean was used for the numerical data, and frequency for the categorical data. The homogeneity between the study groups regarding the participants' descriptive characteristics was tested with the Chi-Square test. Repeated measures analysis of variance (ANOVA) was used to identify the differences between the study groups, meanwhile within-group comparisons were done by the Independent Sample t-Test. The power analyses conducted with G*Power indicated that this study had high power (1 - β = 0.93) with the effect size of d=0.91 (α=0,05).
- Conditions
- Surgery, Cardiac Disease
- Being tested
- Positive Self-Affirmation
- Keywords
- anxiety, discomfort, open-heart surgery, self-affirmation, randomized controlled trial
- Medical subject headings
- Heart Diseases, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Self-AffirmationBehavioural
Each participant of the intervention group was given a set of earphones and an MP3 player which included an audio recording with a background sound of birds crowing and river-like flowing water together with the positive affirmation sentences. The self-affirmation sentences were created by the first author by paying special attention to not using negative predicates and words with negative meanings such as pain, nausea, and discomfort. In the audio recording, the affirmative sentences were verbalized by the first author with a soothing voice. Between each sentence, a pause is given so that the patient can repeat each sentence verbally or internally. The audio recording lasted 5 minutes 40 seconds and the patients were asked to listen to it at least once a day, however, they were encouraged to listen to it as much as they wanted.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Self-affirmation audio recording included 40 positive sentences in order to increase the sensation of well-being of the patients. Some examples are:
1. Now I have decided to think more positively.
2. I am in control of my thoughts.
3. I am completely relaxed.
4. I am strong, and I am aware of my strength.
5. I can be comfortable and positive in any situation.
6. I love myself as I am and accept myself for who I am.
7. I know very well how to relax.
8. All my muscles relax with every deep breath I take.
9. I leave myself in peace.
10. I am a relaxed, joyful, and happy person.
11. I am calm at all times and in all situations.
12. I know that everything that happens in my life happens for my own good.
13. I am very good at relaxing.
14. My life energy is rising.
15. I am surrounded by positive energy.
In the background of the recording there were sounds of birds crowing and river-like flowing water together for increasing the effect of relaxation. Receives: Behavioral: Positive Self-Affirmation |
| Control Group | No intervention | The participants of the control group only received the conventional care given in the inpatient clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the level of state anxiety on 3 consecutive days
The primary outcome of the study was the level of state anxiety during the postoperative stay in the in-patient clinic. The State Trait Anxiety Inventory (STAI) was used to measure the level of anxiety. It is a 40 item, 4-point Likert scale ranging from 1 (not at all) to 4 (very much so) and consisting of two sub-dimensions; state anxiety and trait anxiety, 20 items each. The scale was developed by Spielberger et al. in 1970 and adapted to Turkish by Öner and LeCompte in 1983. The total score ranges from 20 to 80 where higher scores indicate higher levels of anxiety. For the subsequent measurements of anxiety, only the state dimension of the STAI was used.
Measured: During 3 days, one measurement per day
Secondary outcomes (5)
Change in the perceived level of pain on 3 consecutive days, measured by 0 to 10 numeric rating scale
Patients' level of perceived discomfort regarding pain was measured by a Numeric Rating Scale (NRS) of 0 to 10 where higher scores indicate more pain.
Measured: During 3 days, one measurement per day
Change in the perceived level of dyspnoea on 3 consecutive days, measured by 0 to 10 numeric rating scale
Patients' level of perceived discomfort regarding dyspnoea was measured by a Numeric Rating Scale (NRS) of 0 to 10 where higher scores indicate more dyspnoea.
Measured: During 3 days, one measurement per day
Change in the perceived level of palpitations on 3 consecutive days, measured by 0 to 10 numeric rating scale
Patients' level of perceived discomfort regarding palpitations was measured by a Numeric Rating Scale (NRS) of 0 to 10 where higher scores indicate more palpitations.
Measured: During 3 days, one measurement per day
Change in the perceived level of fatigue on 3 consecutive days, measured by 0 to 10 numeric rating scale
Patients' level of perceived discomfort regarding fatigue was measured by a Numeric Rating Scale (NRS) of 0 to 10 where higher scores indicate more fatigue.
Measured: During 3 days, one measurement per day
Change in the perceived level of nausea on 3 consecutive days, measured by 0 to 10 numeric rating scale
Patients' level of perceived discomfort regarding nausea was measured by a Numeric Rating Scale (NRS) of 0 to 10 where higher scores indicate more nausea.
Measured: During 3 days, one measurement per day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start30 Jul 2019
- Primary completion20 Mar 2020
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (52)Papers the sponsor has linked to this study.
- Other trials for 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised assignation of participants into two study groups: Intervention and Control.
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vic - Central University of Catalonia
- Sponsor type
- University, hospital or other
- Collaborators
- Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery and Research Hospital, Trakya University
- Responsible party
- Principal investigator, Meltem Yildirim, University of Vic - Central University of Catalonia
- Investigators
- Meltem Yildirim, PhD, Principal investigator, University of Vic - Central University of Catalonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05487430
- Sponsor's protocol ID
- 2019-52
- Status last verified
- Aug 2022
- First submitted
- 21 Jul 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study will not be publicly available due to the privacy of the participants.
Publications
Hernandez-Palazon J, Fuentes-Garcia D, Falcon-Arana L, Roca-Calvo MJ, Burguillos-Lopez S, Domenech-Asensi P, Jara-Rubio R. Assessment of Preoperative Anxiety in Cardiac Surgery Patients Lacking a History of Anxiety: Contributing Factors and Postoperative Morbidity. J Cardiothorac Vasc Anesth. 2018 Feb;32(1):236-244. doi: 10.1053/j.jvca.2017.04.044. Epub 2017 Apr 26.
PubMed 28803768Williams JB, Alexander KP, Morin JF, Langlois Y, Noiseux N, Perrault LP, Smolderen K, Arnold SV, Eisenberg MJ, Pilote L, Monette J, Bergman H, Smith PK, Afilalo J. Preoperative anxiety as a predictor of mortality and major morbidity in patients aged >70 years undergoing cardiac surgery. Am J Cardiol. 2013 Jan 1;111(1):137-42. doi: 10.1016/j.amjcard.2012.08.060.
PubMed 23245838Bang YY, Park H. Effects of auricular acupressure on the quality of sleep and anxiety in patients undergoing cardiac surgery: A single-blind, randomized controlled trial. Appl Nurs Res. 2020 Jun;53:151269. doi: 10.1016/j.apnr.2020.151269. Epub 2020 Apr 19.
PubMed 32451010Sherman DK. Self-Affirmation: Understanding the Effects. Soc Personal Psychol Compass 2013;7:834-45.
Steele CM. The Psychology of Self-Affirmation: Sustaining the Integrity of the Self. 1988, 261-302.
Sherman DK, Cohen GL. The Psychology of Self-defense: Self-Affirmation Theory. Advances in Experimental Social Psychology. 2006, 183-242.
Creswell JD, Lam S, Stanton AL, Taylor SE, Bower JE, Sherman DK. Does self-affirmation, cognitive processing, or discovery of meaning explain cancer-related health benefits of expressive writing? Pers Soc Psychol Bull. 2007 Feb;33(2):238-50. doi: 10.1177/0146167206294412.
PubMed 17259584Yildirim M, Gulsoy H, Batmaz M, Ozgat C, Yesilbursali G, Aydin R, Ekiz S. Symptom Management: The Effects of Self-Affirmation on Chemotherapy-Related Symptoms. Clin J Oncol Nurs. 2017 Feb 1;21(1):E15-E22. doi: 10.1188/17.CJON.E15-E22.
PubMed 28107336Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c869. doi: 10.1136/bmj.c869. No abstract available.
PubMed 20332511Spielberger CD, Gorsuch RL, Lushene RE. Test Manual for the State Trait Anxiety Inventory. 1st Ed. California: Consulting Psychologists Press, 1970.
Öner N, LeCompte AW. Stait Trait Anxiety Inventory Handbook (Süreksiz Durumluk/Sürekli Kaygı Envanteri El Kitabı). 1st Ed. Istanbul: Bogazici Universitesi Yayinlari, 1983.
Gift AG, Narsavage G. Validity of the numeric rating scale as a measure of dyspnea. Am J Crit Care. 1998 May;7(3):200-4.
PubMed 9579246Gladman D, Nash P, Goto H, Birt JA, Lin CY, Orbai AM, Kvien TK. Fatigue numeric rating scale validity, discrimination and responder definition in patients with psoriatic arthritis. RMD Open. 2020 Jan;6(1):e000928. doi: 10.1136/rmdopen-2019-000928.
PubMed 31958274Wikstrom L, Nilsson M, Brostrom A, Eriksson K. Patients' self-reported nausea: Validation of the Numerical Rating Scale and of a daily summary of repeated Numerical Rating Scale scores. J Clin Nurs. 2019 Mar;28(5-6):959-968. doi: 10.1111/jocn.14705. Epub 2018 Nov 8.
PubMed 30357970Harden M, Nystrom B, Kulich K, Carlsson J, Bengtson A, Edvardsson N. Validity and reliability of a new, short symptom rating scale in patients with persistent atrial fibrillation. Health Qual Life Outcomes. 2009 Jul 15;7:65. doi: 10.1186/1477-7525-7-65.
PubMed 19604399
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Self-Affirmation on Anxiety and Perceived Discomfort in Patients Who Underwent Open-Heart Surgery. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05487430
- Acronym / sponsor ID
- 2019-52
- Conditions
- Surgery, Cardiac Disease
- Keywords
- anxiety, discomfort, open-heart surgery, self-affirmation, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of Vic - Central University of CataloniaUniversity, hospital or other
- Collaborators
- Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery and Research Hospital, Trakya University
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 4 Aug 2022 (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.
This study adopted a randomized controlled pretest-posttest follow-up research design. The study was conducted at a public training and research hospital (Istanbul, Turkey) specialized in thoracic and cardiovascular surgery. The sample consisted of 61 patients randomized into two groups: intervention (n=34) and control (n=27). The participants of the intervention group listened to a self-affirmation audio recording for three days after surgery. Anxiety levels and perceived discomfort regarding pain, dyspnoea, palpitations, fatigue and nausea were measured daily. The study's main question is How do self-affirmation affect postoperative anxiety and perceived discomfort (regarding pain, dyspnoea, palpitations, fatigue and nausea) in patients who undergo open-heart surgery? In accordance with this question, the hypotheses was that repetitive positive self-affirmations decrease both anxiety and perceived discomfort in patients who underwent open-heart surgery.
Detailed description
This study adopted a randomized controlled pretest-posttest follow-up research design in accordance with CONSORT guidelines with 2 study groups (intervention and control).
The study was conducted among the patients who underwent open-heart surgery in the in-patient clinics of a public hospital (Istanbul, Turkey). Following the surgical intervention, all patients were admitted to the cardiac intensive care unit (CICU) for close postoperative follow-up. According to the hospital protocol, the minimum duration for a CICU stay is 2 days after surgery in patients that are hemodynamically stabilized. On their 3rd postoperative day, they are discharged from CICU to be admitted to the in-patient clinic and; in this study, their first day in the clinic was considered as the adaptation and resting period, so that the sampling process was started on the 4th postoperative day.
Eighty-five patients were assessed for eligibility. Five patients excluded from the study before randomization. Following the randomization, 12 patients were excluded during the initial allocation and then 7 more patients were excluded during the follow-up. The final study sample consisted of 61 patients who underwent CABS; 34 in the intervention group and 27 in the control group.
The baseline data (pre-test) was obtained on the fourth postoperative day considering the fact that the patients were comfortably adapted to the in-patient clinic and were more open to collaborate in the study. Additionally, preoperative anxiety weren't considered as a baseline evaluation because it is known that during the preoperative period the sources of anxiety are mainly related to uncertainties and fear of death, however during the postoperative period the patients are more likely to be concerned about their need to be protected, in other words, their vulnerability and fragility.
Each patient was followed up for 3 days. The data collection process was lasted 4 months, between the 20th of November of 2019 and the 20th of March of 2020.
In this study, intention-to-treat analysis was not used as all the participants were asked to listen to the self-affirmation recording at least once a day, because daily repetition is the key element when affirming positive sentences in order to mobilize the inner sources of the individual. Therefore, only per-protocol analysis where all participants strictly adhered to the study protocol was conducted.
The data were analysed by using the Statistical Package for the Social Sciences (IBM, SPSS, 21.0) at a significance level of 0.05. In the descriptive analysis, mean was used for the numerical data, and frequency for the categorical data. The homogeneity between the study groups regarding the participants' descriptive characteristics was tested with the Chi-Square test. Repeated measures analysis of variance (ANOVA) was used to identify the differences between the study groups, meanwhile within-group comparisons were done by the Independent Sample t-Test. The power analyses conducted with G*Power indicated that this study had high power (1 - β = 0.93) with the effect size of d=0.91 (α=0,05).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised assignation of participants into two study groups: Intervention and Control.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Positive Self-AffirmationSelf-affirmation audio recording included 40 positive sentences in order to increase the sensation of well-being of the patients. Some examples are: 1. Now I have decided to think more positively. 2. I am in control of my thoughts. 3. I am completely relaxed. 4. I am strong, and I am aware of my strength. 5. I can be comfortable and positive in any situation. 6. I love myself as I am and accept myself for who I am. 7. I know very well how to relax. 8. All my muscles relax with every deep breath I take. 9. I leave myself in peace. 10. I am a relaxed, joyful, and happy person. 11. I am calm at all times and in all situations. 12. I know that everything that happens in my life happens for my own good. 13. I am very good at relaxing. 14. My life energy is rising. 15. I am surrounded by positive energy. In the background of the recording there were sounds of birds crowing and river-like flowing water together for increasing the effect of relaxation. |
| Control Group | No intervention | –The participants of the control group only received the conventional care given in the inpatient clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- undergoing coronary artery bypass surgery for the first time,
- not having any history of a previous open cardiothoracic surgery
- being over 18 years
- being literate in Turkish.
Key exclusion criteria (4 listed)
- having a diagnosed anxiety disorder
- having hearing deficiency
- having an emergency coronary artery bypass surgery
- staying in the cardiac intensive care unit for more than 48-hours
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 |
|---|---|---|
| Positive Self-AffirmationEach participant of the intervention group was given a set of earphones and an MP3 player which included an audio recording with a background sound of birds crowing and river-like flowing water together with the positive affirmation sentences. The self-affirmation sentences were created by the first author by paying special attention to not using negative predicates and words with negative meanings such as pain, nausea, and discomfort. In the audio recording, the affirmative sentences were verbalized by the first author with a soothing voice. Between each sentence, a pause is given so that the patient can repeat each sentence verbally or internally. The audio recording lasted 5 minutes 40 seconds and the patients were asked to listen to it at least once a day, however, they were encouraged to listen to it as much as they wanted. | Behavioural | Intervention Group |
Primary outcome
Change in the level of state anxiety on 3 consecutive days
Time frame: During 3 days, one measurement per day
The primary outcome of the study was the level of state anxiety during the postoperative stay in the in-patient clinic. The State Trait Anxiety Inventory (STAI) was used to measure the level of anxiety. It is a 40 item, 4-point Likert scale ranging from 1 (not at all) to 4 (very much so) and consisting of two sub-dimensions; state anxiety and trait anxiety, 20 items each. The scale was developed by Spielberger et al. in 1970 and adapted to Turkish by Öner and LeCompte in 1983. The total score ranges from 20 to 80 where higher scores indicate higher levels of anxiety. For the subsequent measurements of anxiety, only the state dimension of the STAI was used.
5 secondary outcomes
Change in the perceived level of pain on 3 consecutive days, measured by 0 to 10 numeric rating scale
Time frame: During 3 days, one measurement per day
Change in the perceived level of dyspnoea on 3 consecutive days, measured by 0 to 10 numeric rating scale
Time frame: During 3 days, one measurement per day
Change in the perceived level of palpitations on 3 consecutive days, measured by 0 to 10 numeric rating scale
Time frame: During 3 days, one measurement per day
Change in the perceived level of fatigue on 3 consecutive days, measured by 0 to 10 numeric rating scale
Time frame: During 3 days, one measurement per day
Change in the perceived level of nausea on 3 consecutive days, measured by 0 to 10 numeric rating scale
Time frame: During 3 days, one measurement per day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Background: PubMed 28803768Hernandez-Palazon J, Fuentes-Garcia D, Falcon-Arana L, Roca-Calvo MJ, Burguillos-Lopez S, Domenech-Asensi P, Jara-Rubio R. Assessment of Preoperative Anxiety in Cardiac Surgery Patients Lacking a History of Anxiety: Contributing Factors and Postoperative Morbidity. J Cardiothorac Vasc Anesth. 2018 Feb;32(1):236-244. doi: 10.1053/j.jvca.2017.04.044. Epub 2017 Apr 26.
- Background: PubMed 23245838Williams JB, Alexander KP, Morin JF, Langlois Y, Noiseux N, Perrault LP, Smolderen K, Arnold SV, Eisenberg MJ, Pilote L, Monette J, Bergman H, Smith PK, Afilalo J. Preoperative anxiety as a predictor of mortality and major morbidity in patients aged >70 years undergoing cardiac surgery. Am J Cardiol. 2013 Jan 1;111(1):137-42. doi: 10.1016/j.amjcard.2012.08.060.
- Background: PubMed 32451010Bang YY, Park H. Effects of auricular acupressure on the quality of sleep and anxiety in patients undergoing cardiac surgery: A single-blind, randomized controlled trial. Appl Nurs Res. 2020 Jun;53:151269. doi: 10.1016/j.apnr.2020.151269. Epub 2020 Apr 19.
- BackgroundSherman DK. Self-Affirmation: Understanding the Effects. Soc Personal Psychol Compass 2013;7:834-45.
- BackgroundSteele CM. The Psychology of Self-Affirmation: Sustaining the Integrity of the Self. 1988, 261-302.
- BackgroundSherman DK, Cohen GL. The Psychology of Self-defense: Self-Affirmation Theory. Advances in Experimental Social Psychology. 2006, 183-242.
- Background: PubMed 17259584Creswell JD, Lam S, Stanton AL, Taylor SE, Bower JE, Sherman DK. Does self-affirmation, cognitive processing, or discovery of meaning explain cancer-related health benefits of expressive writing? Pers Soc Psychol Bull. 2007 Feb;33(2):238-50. doi: 10.1177/0146167206294412.
- Background: PubMed 28107336Yildirim M, Gulsoy H, Batmaz M, Ozgat C, Yesilbursali G, Aydin R, Ekiz S. Symptom Management: The Effects of Self-Affirmation on Chemotherapy-Related Symptoms. Clin J Oncol Nurs. 2017 Feb 1;21(1):E15-E22. doi: 10.1188/17.CJON.E15-E22.
- Background: PubMed 20332511Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c869. doi: 10.1136/bmj.c869. No abstract available.
- BackgroundSpielberger CD, Gorsuch RL, Lushene RE. Test Manual for the State Trait Anxiety Inventory. 1st Ed. California: Consulting Psychologists Press, 1970.
- BackgroundÖner N, LeCompte AW. Stait Trait Anxiety Inventory Handbook (Süreksiz Durumluk/Sürekli Kaygı Envanteri El Kitabı). 1st Ed. Istanbul: Bogazici Universitesi Yayinlari, 1983.
- Background: PubMed 9579246Gift AG, Narsavage G. Validity of the numeric rating scale as a measure of dyspnea. Am J Crit Care. 1998 May;7(3):200-4.
- Individual participant dataSharing planned: No. The data that support the findings of this study will not be publicly available due to the privacy of the participants.
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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.
Meltem Yildirim, PhD principal investigator
University of Vic - Central University of Catalonia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Self-Affirmation in people with Surgery and Cardiac Disease, run by University of Vic - Central University of Catalonia 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 4 Aug 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the level of state anxiety on 3 consecutive days (time frame: During 3 days, one measurement per day). 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 NCT05487430, which also lists 52 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 4 Aug 2022.