The Effect of Progressive Relaxation Exercise on Physiological Parameters, Pain and Anxiety in Patients Undergoing Colorectal Cancer Surgery: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Preoperative pain severity
研究概览
简要总结
This research was carried out as an pre-test/post-test control group experimental design study in order to determine the effect of progressive relaxation exercises on the level of vital sign, pain and anxiety underwent who laparoscopic surgery for colorectal cancer in patients. This research data was collected between March 2018 and May 2019. The research was carried out with 63 patients (experiment group= 31, control group= 32) who underwent elective laparoscopic colorectal surgery in a general surgery clinic of a university hospital in Istanbul and in accordance with the research criteria. Patients in the experiment group were taught breathing exercises in the preoperative period and on the 1st, 2nd and 3rd day after surgery then, progressive relaxation exercise that lasted 15 minutes was applied to the group. Pain (Short McGill Pain Scale) and anxiety (STAI-S Scale) levels of both groups were evaluated in the preoperative and postoperative period. The patient's vital signs, oxygen saturation and serum cortisol level parameters were measured in the same time interval before and after the relaxation exercise. Significance was evaluated at p <0.05 and p<0,001 levels in the analysis of the data. Prior to the study, the consent of the institution and ethics committee, written and verbal patient consent were obtained.
详细描述
The universe of the study consisted of patients with colorectal cancer who were admitted to Istanbul University, Istanbul Faculty of Medicine, General Surgery Clinics for treatment between March 2018 and May 2019 and who would undergo laparoscopic surgery.The research was planned as a randomized controlled experimental study. Block randomization method was to determine the experimental and control groups. In order for the groups to be distributed homogeneously, the order produced by a computer program(https://www.randomizer.org/) was used. Randomization done by a biostatistician outside the researcher. Patients who meet the inclusion criteria and agree to participate in the study assigned to the experimental and control groups according the randomization list.Research data will be collected in a hospital's general surgery ward between March 2018 and May 2019. The independent variable of the study is Progressive Relaxation Exercise.The dependent variables of the study are physiological parameters, pain, anxiety and serum cortisol. In the research, "Individual Characteristics Form" and "Patient Follow-up Form" prepared by the researcher in line with the literature will be used as data collection tools.
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
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
- •Being 18 years or over,
- •Consenting to participate in the study with verbal and written declaration after being informed,
- •Being scheduled for elective laparoscopic colorectal cancer surgery,
- •Not participating in another randomized controlled study simultaneously.
排除标准
- •Having a health problem that will alter cortisol release,
- •Preoperative and postoperative unconsciousness,
- •Having a psychiatric problem,
- •Having a disease that requires corticosteroid therapy,
- •Developing any complications during the operation.
结局指标
主要结局
Preoperative pain severity
时间窗: Preoperative pain assessment of the groups was made 2 hours before surgery.
Pain severity assessment with Short Form McGill Pain Questionnaire In the first part, pain intensity is evaluated as 0=no pain, 1=mild pain, 2=moderate pain, 3=severe pain In the second part, the pain felt is evalauted using the Visuel Analog Scale (VAS).0-10; 0- No Pain, 10- Worst pain In the third part, the total pain intensity is measured with a 6-point Likert-type assessment. (0=no pain, 1=mild, 2=annoying , 3=troublesome, 4=miserable, 5=unbearable pain) Pain assessment for the experimental group Preoperative pain assessment of the experimental group was made before applying the progressive relaxation exercise. This evaluation was made 2 hours before surgery (6.30 am). Pain assessment for the control group Preoperative pain assessment of the control group was made 2 hours before the operation in order to ensure the equivalence between the groups (6.30 am).
Preoperative anxiety severity
时间窗: Preoperative anxiety assessment of the groups was made 2 hours before surgery.
Anxiety severity with Spielberger's State and Trait Anxiety Inventory State Anxiety Subscale are specified by choosing one of the options "1) not at all, 2) somewhat, 3) moderately so, and 4) very much so" according to the severity of such experiences. Anxiety assessment for the experimental group Preoperative anxiety assessment of the experimental group was made before applying the progressive relaxation exercise. This evaluation was made 2 hours before surgery (6.30 am). Anxiety assessment for the control group Preoperative anxiety assessment of the control group was made 2 hours before the operation in order to ensure the equivalence between the groups (6.30 am).
Preoperative systolic and diastolic blood pressure (mmHg) (1st. assessment)
时间窗: In the preoperative period, systolic and diastolic blood pressure (mmHg) evaluations were made 2 hours before surgery.
Systolic and diastolic blood pressure (mmHg) evaluations were made with a digital blood pressure measuring device. For experimental group The first evaluation was made before applying the progressive relaxation exercise(6.30 am). For the control group The first evaluation was made 6.30am.
Preoperative body temperature (Celcius) (1st. assessment)
时间窗: In the preoperative period, body temperature was evaluated 2 hours before surgery
Body temperature (Celcius)assessment was made with a digital thermometer. For the experimental group The first evaluation was made before applying the progressive relaxation exercise (6.30am). For the control group The first evaluation was made 6.30am.
Use of analgesic (See Table 1)(in the first 24 hours after surgery)
时间窗: Analgesic consumption of the patients was recorded in the first 24 hours after surgery.
In this section, dose (mg) of use of analgesics were followed. Table 1: Monitoring of analgesic use of patients Analgesic name Dose (mg) Postoperative 0 Opioid NSAİ Other
Preoperative pulse rate (heart rate per minute) (2nd. assessment)
时间窗: In the preoperative period, the pulse rate was evaluated 1 hour before surgery.
Respiratory rate (respiratory per minute) evaluation was made by the researcher by counting 1 minute. For the experimental group Progressive relaxation exercise was applied, the second evaluation was made 5 minutes after the application (7.20am.). For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 7.20am.
Preoperative oxygen saturation (SpO2) (2nd. assessment)
时间窗: In the preoperative period, oxygen saturation was evaluated 1 hour before surgery.
Oxygen saturation (SpO2) was evaluated with a pulse oximeter. For the experimental group Progressive relaxation exercise was applied, the second evaluation was made 5 minutes after the application (7.20am.). For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 7.20am.
Preoperative serum cortisol levels (1st. assessment)
时间窗: In the preoperative period, serum cortisol levels assessment of the groups was made 2 hours before surgery.
Blood samples were placed in tubes containing separator gel (SST-yellow tube) and serum cortisol level was analyzed in the relevant laboratory. For the experimental group The first evaluation was made before applying the progressive relaxation exercise (6.45 am). For the control group The first evaluation was made 6.45am.
Preoperative systolic and diastolic blood pressure (mmHg) (2nd. assessment)
时间窗: In the preoperative period, systolic and diastolic blood pressure (mmHg) evaluations were made 1 hour before surgery.
Systolic and diastolic blood pressure (mmHg) evaluations were made with a digital blood pressure measuring device. For experimental group Progressive relaxation exercise was applied, the second evaluation was made 5 minutes after the application (7.20am.). For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 7.20am.
Preoperative pulse rate (heart rate per minute) (1st. assessment)
时间窗: In the preoperative period, the pulse rate was evaluated 2 hours before surgery.
Pulse rate (heart rate per minute) evaluation was made with a digital pulse-meter. For the experimental group The first evaluation was made before applying the progressive relaxation exercise (6.30 am). For the control group The first evaluation was made 6.30am.
Preoperative serum cortisol levels (2nd. assessment)
时间窗: In the preoperative period, serum cortisol levels assessment of the groups was made 1 hour before surgery.
Blood samples were placed in tubes containing separator gel (SST-yellow tube) and serum cortisol level was analyzed in the relevant laboratory. For the experimental group Progressive relaxation exercise was applied, the second evaluation was made 45 minutes after the application (8.00am.). For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 8.00am.
Use of analgesic (See Table 1)(postoperative 2nd day)
时间窗: Analgesic consumption of the patients was recorded in the postoperative 2nd. day.
In this section, dose of use of analgesics were followed. Table 1: Monitoring of analgesic use of patients Analgesic name Dose (mg) Postoperative 2 Opioid NSAİ Other
Use of analgesic (See Table 1)(postoperative 3rd day)
时间窗: Analgesic consumption of the patients was recorded in the postoperative 3rd. days.
In this section, dose of use of analgesics were followed. Table 1: Monitoring of analgesic use of patients Analgesic name Dose (mg) Postoperative 3 Opioid NSAİ Other
Preoperative respiratory rate (respiratory per minute) (1st. assessment)
时间窗: In the preoperative period, respiratory rate was evaluated 2 hours before surgery.
Respiratory rate (respiratory per minute) evaluation was made by the researcher by counting 1 minute. For the experimental group The first evaluation was made before applying the progressive relaxation exercise (6.30am). For the control group The first evaluation was made 6.30am.
Preoperative oxygen saturation (SpO2) (1st. assessment)
时间窗: In the preoperative period, oxygen saturation was evaluated 2 hours before surgery.
Oxygen saturation (SpO2) was evaluated with a pulse oximeter. For the experimental group The first evaluation was made before applying the progressive relaxation exercise (6.30am). For the control group The first evaluation was made 6.30am.
Preoperative respiratory rate (respiratory per minute) (2nd. assessment)
时间窗: In the preoperative period, respiratory rate was evaluated 1 hour before surgery.
Respiratory rate (respiratory per minute) evaluation was made by the researcher by counting 1 minute. For the experimental group Progressive relaxation exercise was applied, the second evaluation was made 5 minutes after the application (7.20am.). For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 7.20am.
Preoperative body temperature (Celcius) (2nd. assessment)
时间窗: In the preoperative period, body temperature was evaluated 1 hour before surgery.
Body temperature (Celcius)assessment was made with a digital thermometer. For the experimental group Progressive relaxation exercise was applied, the second evaluation was made 5 minutes after the application (7.20am.). For the control group Progressive relaxation exercise wasn't applied because of was control group, the second evaluation was made 7.20am.
Use of analgesic (See Table 1)(postoperative 1st. day)
时间窗: Analgesic consumption of the patients was recorded in the postoperative 1st. day.
In this section, dose of use of analgesics were followed. Table 1: Monitoring of analgesic use of patients Analgesic name Doses (mg) Postoperative 1 Opioid NSAİ Other
次要结局
- Postoperative anxiety severity(Postoperative anxiety assessment of the groups was made postoperative 3rd. day.)
- Postoperative systolic and diastolic blood pressure (mmHg) (1st. assessment)(Systolic and diastolic blood pressure (mmHg) evaluations were made on postoperative 1st. day.)
- Postoperative systolic and diastolic blood pressure (mmHg) (2nd. assessment)(Systolic and diastolic blood pressure (mmHg) evaluations were made on postoperative 2nd. day.)
- Postoperative systolic and diastolic blood pressure (mmHg) (3rd. assessment)(Systolic and diastolic blood pressure (mmHg) evaluations were made on postoperative 3rd. day.)
- Postoperative respiratory rate (respiratory per minute) (2nd. assessment)(Respiratory rate (respiratory per minute) evaluations was made on postoperative 2nd. day.)
- Postoperative body temperature (celcius) (1st. assessment)(Body temperature (0C) evaluation was made on postoperative 1st. day.)
- Postoperative pain severity(Postoperative pain assessment of the groups was made postoperative 3rd. day.)
- Postoperative pulse rate (heart rate per minute) (2nd. assessment)(Pulse rate (heart rate per minute) evaluation was made on postoperative 2nd. day.)
- Postoperative pulse rate (heart rate per minute) (1st. assessment)(Pulse rate (heart rate per minute) evaluation was made on postoperative 1st. day.)
- Postoperative respiratory rate (respiratory per minute) (1st. assessment)(Respiratory rate (respiratory per minute) evaluations was made on postoperative 1st. day.)
- Postoperative pulse rate (heart rate per minute) (3rd. assessment)(Pulse rate (heart rate per minute) evaluation was made on postoperative 3rd. day.)
- Postoperative respiratory rate (respiratory per minute) (3rd. assessment)(Respiratory rate (respiratory per minute) evaluations was made on postoperative 3rd. day.)
- Postoperative body temperature (celcius) (2nd. assessment)(Body temperature (0C) evaluation was made on postoperative 2nd. day.)
- Postoperative body temperature (celcius) (3rd. assessment)(Body temperature (0C) evaluation was made on postoperative 3rd. day.)
- Postoperative oxygen saturation (SpO2) (1st. assessment)(Oxygen saturation (SpO2) evaluation was made on postoperative 1st. day.)
- Postoperative oxygen saturation (SpO2) (3rd. assessment)(Oxygen saturation (SpO2) evaluation was made on postoperative 3rd. day.)
- Postoperative serum cortisol levels (2nd. assessment)(In the postoperative period, serum cortisol levels assessment of the groups was made on postoperative 2nd. day.)
- Postoperative oxygen saturation (SpO2) (2nd. assessment)(Oxygen saturation (SpO2) evaluation was made on postoperative 2nd. day.)
- Postoperative serum cortisol levels (1st. assessment)(In the postoperative period, serum cortisol levels assessment of the groups was made on postoperative 1st. day.)
- Postoperative serum cortisol levels (3rd. assessment)(In the postoperative period, serum cortisol levels assessment of the groups was made on postoperative 3rd. day.)
研究者
YASEMİN ÖZHANLI
Research Assistant Doctor
Kocaeli University