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

NCT04731428 | Completed DMC

• 1 other identifier: 2018/141525
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Nursing Caries; Anxiety

Keywords

Progressive relaxation exercise; Colorectal cancer surgery; Pain; Anxiety; Nursing care

Outcome Measures

Primary Outcomes (18)

• Preoperative pain severity

  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 pain assessment of the groups was made 2 hours before surgery.

• Preoperative anxiety severity

  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 anxiety assessment of the groups was made 2 hours before surgery.

• Preoperative systolic and diastolic blood pressure (mmHg) (1st. assessment)

  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.

  In the preoperative period, systolic and diastolic blood pressure (mmHg) evaluations were made 2 hours before surgery.

• Preoperative pulse rate (heart rate per minute) (1st. assessment)

  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.

  In the preoperative period, the pulse rate was evaluated 2 hours before surgery.

• Preoperative respiratory rate (respiratory per minute) (1st. assessment)

  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.

  In the preoperative period, respiratory rate was evaluated 2 hours before surgery.

• Preoperative body temperature (Celcius) (1st. assessment)

  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.

  In the preoperative period, body temperature was evaluated 2 hours before surgery

• Preoperative oxygen saturation (SpO2) (1st. assessment)

  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.

  In the preoperative period, oxygen saturation was evaluated 2 hours before surgery.

• Preoperative serum cortisol levels (1st. assessment)

  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.

  In the preoperative period, serum cortisol levels assessment of the groups was made 2 hours before surgery.

• Use of analgesic (See Table 1)(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

  Analgesic consumption of the patients was recorded in the first 24 hours after surgery.

• Preoperative systolic and diastolic blood pressure (mmHg) (2nd. assessment)

  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.

  In the preoperative period, systolic and diastolic blood pressure (mmHg) evaluations were made 1 hour before surgery.

• Preoperative pulse rate (heart rate per minute) (2nd. assessment)

  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.

  In the preoperative period, the pulse rate was evaluated 1 hour before surgery.

• Preoperative respiratory rate (respiratory per minute) (2nd. assessment)

  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.

  In the preoperative period, respiratory rate was evaluated 1 hour before surgery.

• Preoperative body temperature (Celcius) (2nd. assessment)

  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.

  In the preoperative period, body temperature was evaluated 1 hour before surgery.

• Preoperative oxygen saturation (SpO2) (2nd. assessment)

  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.

  In the preoperative period, oxygen saturation was evaluated 1 hour before surgery.

• Preoperative serum cortisol levels (2nd. assessment)

  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.

  In the preoperative period, serum cortisol levels assessment of the groups was made 1 hour before surgery.

• Use of analgesic (See Table 1)(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

  Analgesic consumption of the patients was recorded in the postoperative 1st. day.

• Use of analgesic (See Table 1)(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

  Analgesic consumption of the patients was recorded in the postoperative 2nd. day.

• Use of analgesic (See Table 1)(postoperative 3rd day)

  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

  Analgesic consumption of the patients was recorded in the postoperative 3rd. days.

Secondary Outcomes (20)

• Postoperative pain severity

  Postoperative pain assessment of the groups was made postoperative 3rd. day.

• 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.

Study Arms (2)

Progressive Relaxation Exercise

EXPERIMENTAL

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.

Behavioral: Progressive Relaxation Exercise

Standard Care

NO INTERVENTION

In the control group, no application made during and after the surgical intervention, and routine treatment and care applied.

Interventions

Progressive Relaxation Exercise BEHAVIORAL

Progressive Relaxation Exercise involves stretching sixteen muscle groups while breathing in sequentially, relaxing while exhaling. Exercise can be from head to toe or from foot to head. In order for the technique to be effective, it is important to have affective (music, etc.) and visual aids. During the exercise, the patient should complete the processes of perceiving the tension in his body, maintaining control and getting into a state of relaxation. After the patient is informed about the exercise, the person starts with breathing exercises. A deep but relaxing breath is taken from the nose, and lips are given by contracting simultaneously with relaxation. During this application, the patient keeps contracting the muscle group that he exercises for 10 seconds; the nurse provides the patient to notice the temperature / warming felt in the muscle group.

Progressive Relaxation Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• YASEMİN ÖZHANLI: lead

Study Sites (1)

Istanbul University-Istanbul Medical Faculty Hospital

Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 34903440 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Study Officials

• Nuray Akyüz, Assoc. Prof.

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

• Yasemin Özhanlı, PhD

  Istanbul University - Cerrahpasa

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant Doctor

Model Details: Randomized Controlled Study

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: February 1, 2021
• Study Start: March 15, 2018
• Primary Completion: May 30, 2019
• Study Completion: June 10, 2020
• Last Updated: February 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)