The Effect of Self-Affirmation on Anxiety and Perceived Discomfort in Patients Who Underwent Open-Heart Surgery. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Change in the level of state anxiety on 3 consecutive days
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Blinding the intervention group from the clinical staff and from the researchers was not possible due to the fact that the patients were listening to the affirmation recordings.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Intervention Group
Self-affirmation audio recording included 40 positive sentences in order to increase the sensation of well-being of the patients. Some examples are:
- Now I have decided to think more positively.
- I am in control of my thoughts.
- I am completely relaxed.
- I am strong, and I am aware of my strength.
- I can be comfortable and positive in any situation.
- I love myself as I am and accept myself for who I am.
- I know very well how to relax.
- All my muscles relax with every deep breath I take.
- I leave myself in peace.
- I am a relaxed, joyful, and happy person.
- I am calm at all times and in all situations.
- I know that everything that happens in my life happens for my own good.
- I am very good at relaxing.
- My life energy is rising.
- 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.
干预措施: Positive Self-Affirmation (Behavioral)
Control Group
The participants of the control group only received the conventional care given in the inpatient clinic.
结局指标
主要结局
Change in the level of state anxiety on 3 consecutive days
时间窗: 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.
次要结局
- Change in the perceived level of nausea on 3 consecutive days, measured by 0 to 10 numeric rating scale(During 3 days, one measurement per day)
- Change in the perceived level of pain on 3 consecutive days, measured by 0 to 10 numeric rating scale(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(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(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(During 3 days, one measurement per day)
研究者
Meltem Yildirim
Associated Professor
University of Vic - Central University of Catalonia