Clinical trial NCT04731428: Effect of Progressive Relaxation Exercise on Physiological Parameters, Pain, Anxiety in Colorectal Cancer Surgery
Official title: The Effect of Progressive Relaxation Exercise on Physiological Parameters, Pain and Anxiety in Patients Undergoing Colorectal Cancer Surgery: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Nursing Caries
Anxiety
Keywords: Progressive relaxation exercise
Colorectal cancer surgery
Pain
Anxiety
Nursing care
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2021-02-01
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Study
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Preoperative pain severity
timeFrame: Preoperative pain assessment of the groups was made 2 hours before surgery.
measure: Preoperative anxiety severity
timeFrame: Preoperative anxiety assessment of the groups was made 2 hours before surgery.
measure: Preoperative systolic and diastolic blood pressure (mmHg) (1st. assessment)
timeFrame: In the preoperative period, systolic and diastolic blood pressure (mmHg) evaluations were made 2 hours before surgery.
measure: Preoperative pulse rate (heart rate per minute) (1st. assessment)
timeFrame: In the preoperative period, the pulse rate was evaluated 2 hours before surgery.
measure: Preoperative respiratory rate (respiratory per minute) (1st. assessment)
timeFrame: In the preoperative period, respiratory rate was evaluated 2 hours before surgery.
measure: Preoperative body temperature (Celcius) (1st. assessment)
timeFrame: In the preoperative period, body temperature was evaluated 2 hours before surgery
measure: Preoperative oxygen saturation (SpO2) (1st. assessment)
timeFrame: In the preoperative period, oxygen saturation was evaluated 2 hours before surgery.
measure: Preoperative serum cortisol levels (1st. assessment)
timeFrame: In the preoperative period, serum cortisol levels assessment of the groups was made 2 hours before surgery.
measure: Use of analgesic (See Table 1)(in the first 24 hours after surgery)
timeFrame: Analgesic consumption of the patients was recorded in the first 24 hours after surgery.
measure: Preoperative systolic and diastolic blood pressure (mmHg) (2nd. assessment)
timeFrame: In the preoperative period, systolic and diastolic blood pressure (mmHg) evaluations were made 1 hour before surgery.
measure: Preoperative pulse rate (heart rate per minute) (2nd. assessment)
timeFrame: In the preoperative period, the pulse rate was evaluated 1 hour before surgery.
measure: Preoperative respiratory rate (respiratory per minute) (2nd. assessment)
timeFrame: In the preoperative period, respiratory rate was evaluated 1 hour before surgery.
measure: Preoperative body temperature (Celcius) (2nd. assessment)
timeFrame: In the preoperative period, body temperature was evaluated 1 hour before surgery.
measure: Preoperative oxygen saturation (SpO2) (2nd. assessment)
timeFrame: In the preoperative period, oxygen saturation was evaluated 1 hour before surgery.
measure: Preoperative serum cortisol levels (2nd. assessment)
timeFrame: In the preoperative period, serum cortisol levels assessment of the groups was made 1 hour before surgery.
measure: Use of analgesic (See Table 1)(postoperative 1st. day)
timeFrame: Analgesic consumption of the patients was recorded in the postoperative 1st. day.
measure: Use of analgesic (See Table 1)(postoperative 2nd day)
timeFrame: Analgesic consumption of the patients was recorded in the postoperative 2nd. day.
measure: Use of analgesic (See Table 1)(postoperative 3rd day)
timeFrame: Analgesic consumption of the patients was recorded in the postoperative 3rd. days.
Secondary outcomes:
measure: Postoperative pain severity
timeFrame: Postoperative pain assessment of the groups was made postoperative 3rd. day.
measure: Postoperative anxiety severity
timeFrame: Postoperative anxiety assessment of the groups was made postoperative 3rd. day.
measure: Postoperative systolic and diastolic blood pressure (mmHg) (1st. assessment)
timeFrame: Systolic and diastolic blood pressure (mmHg) evaluations were made on postoperative 1st. day.
measure: Postoperative systolic and diastolic blood pressure (mmHg) (2nd. assessment)
timeFrame: Systolic and diastolic blood pressure (mmHg) evaluations were made on postoperative 2nd. day.
measure: Postoperative systolic and diastolic blood pressure (mmHg) (3rd. assessment)
timeFrame: Systolic and diastolic blood pressure (mmHg) evaluations were made on postoperative 3rd. day.
measure: Postoperative pulse rate (heart rate per minute) (1st. assessment)
timeFrame: Pulse rate (heart rate per minute) evaluation was made on postoperative 1st. day.
measure: Postoperative pulse rate (heart rate per minute) (2nd. assessment)
timeFrame: Pulse rate (heart rate per minute) evaluation was made on postoperative 2nd. day.
measure: Postoperative pulse rate (heart rate per minute) (3rd. assessment)
timeFrame: Pulse rate (heart rate per minute) evaluation was made on postoperative 3rd. day.
measure: Postoperative respiratory rate (respiratory per minute) (1st. assessment)
timeFrame: Respiratory rate (respiratory per minute) evaluations was made on postoperative 1st. day.
measure: Postoperative respiratory rate (respiratory per minute) (2nd. assessment)
timeFrame: Respiratory rate (respiratory per minute) evaluations was made on postoperative 2nd. day.
measure: Postoperative respiratory rate (respiratory per minute) (3rd. assessment)
timeFrame: Respiratory rate (respiratory per minute) evaluations was made on postoperative 3rd. day.
measure: Postoperative body temperature (celcius) (1st. assessment)
timeFrame: Body temperature (0C) evaluation was made on postoperative 1st. day.
measure: Postoperative body temperature (celcius) (2nd. assessment)
timeFrame: Body temperature (0C) evaluation was made on postoperative 2nd. day.
measure: Postoperative body temperature (celcius) (3rd. assessment)
timeFrame: Body temperature (0C) evaluation was made on postoperative 3rd. day.
measure: Postoperative oxygen saturation (SpO2) (1st. assessment)
timeFrame: Oxygen saturation (SpO2) evaluation was made on postoperative 1st. day.
measure: Postoperative oxygen saturation (SpO2) (2nd. assessment)
timeFrame: Oxygen saturation (SpO2) evaluation was made on postoperative 2nd. day.
measure: Postoperative oxygen saturation (SpO2) (3rd. assessment)
timeFrame: Oxygen saturation (SpO2) evaluation was made on postoperative 3rd. day.
measure: Postoperative serum cortisol levels (1st. assessment)
timeFrame: In the postoperative period, serum cortisol levels assessment of the groups was made on postoperative 1st. day.
measure: Postoperative serum cortisol levels (2nd. assessment)
timeFrame: In the postoperative period, serum cortisol levels assessment of the groups was made on postoperative 2nd. day.
measure: Postoperative serum cortisol levels (3rd. assessment)
timeFrame: In the postoperative period, serum cortisol levels assessment of the groups was made on postoperative 3rd. day.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Istanbul Medical Faculty Hospital
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Nuray Akyüz, Assoc. Prof.
role: STUDY_DIRECTOR
affiliation: Istanbul University - Cerrahpasa
name: Yasemin Özhanlı, PhD
role: STUDY_CHAIR
References:
citation: Ozhanli Y, Akyuz N. The Effect of Progressive Relaxation Exercise on Physiological Parameters, Pain and Anxiety Levels of Patients Undergoing Colorectal Cancer Surgery: A Randomized Controlled Study. J Perianesth Nurs. 2022 Apr;37(2):238-246. doi: 10.1016/j.jopan.2021.08.008. Epub 2021 Dec 10.