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Effect of Progressive Relaxation Exercise on Physiological Parameters, Pain, Anxiety in Colorectal Cancer Surgery

Y

YASEMİN ÖZHANLI

Status

Completed

Conditions

Postoperative Pain
Anxiety
Nursing Caries

Treatments

Behavioral: Progressive Relaxation Exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT04731428
2018/141525

Details and patient eligibility

About

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.

Full 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.

Enrollment

63 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

63 participants in 2 patient groups

Progressive Relaxation Exercise
Experimental group
Description:
In individuals with normal daily circadian rhythms, cortisol levels peak at 8:00 AM, followed by a constantly declining daily cycle throughout the day. Therefore, it is important to collect blood samples taken for the measurement of serum cortisol levels approximately at the same time. Venous blood samples (3 ml) were obtained from the upper arm at 06:45 AM to evaluate the baseline and 45 minutes after Progressive Relaxation Exercise at 08:00. Vital signs and oxygen saturation were assessed at 6:30 AM before Progressive Relaxation Exercise and at 07:20 AM 5 minutes after Progressive Relaxation Exercise. Measurements were performed in the morning on the day of surgery and on postoperative days 1, 2, and 3.
Treatment:
Behavioral: Progressive Relaxation Exercise
Standard Care
No Intervention group
Description:
In the control group, no application made during and after the surgical intervention, and routine treatment and care applied.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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