NCT06404710

Brief Summary

Various methods are used to prolong life and improve quality of life in heart diseases. There are surgical treatment options. Heart surgery is a major surgery and surgery Due to common postoperative symptoms, follow-up and follow-up in the early postoperative period maintenance is important.Progressive relaxation exercise; optimization of analgesia, pain management, reduction of side effects, regulation of vital signs, increase in sleep qualityIt has been reported that it provides positive effects on many systems and increases the success of the surgical process. It has been stated in research that it can increase.In this study, patients who had undergone cardiac surgery and were treated as inpatients progressive muscle relaxation in reducing pain, reducing anxiety, and improving the quality of sleep and recovery It was aimed to determine the effect of the exercises.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 30, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 8, 2024

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2024

Completed
Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

8 months

First QC Date

April 30, 2024

Last Update Submit

May 3, 2024

Conditions

Keywords

progressive muscle relaxationanxietyquality of recoveryheart surgerysleeppain

Outcome Measures

Primary Outcomes (3)

  • NUMERICAL RATING SCALE

    This scale contains numbers from 1 to 10. 1: not at all, 10: very much. Patients' pain will be measured.

    First day before surgery, first 4 days after surgery and 20 days after discharge

  • VISUAL COMPARISON SLEEP SCALE

    Each item in the scale is evaluated using a visual comparison technique on a graph between 0 (left end) and 100 (right end), the minimum score that can be obtained from the scale is 0 and the maximum score is 1000. An increase in the score obtained from the scale indicates that sleep quality decreases. It consists of 15 items in total.

    3rd day after surgery and 20 days after discharge

  • State Anxiety Scale

    Anxiety level is scored as "(1) not at all, (2) a little, (3) a lot and (4) completely". The scores obtained from the scale theoretically range between 20 and 80. A high score indicates a high level of anxiety.

    3rd day after surgery and 20 days after discharge

Study Arms (2)

Control

NO INTERVENTION

Scales will be filled in for the control group without any progressive relaxation exercise.

Exercise

EXPERIMENTAL

Scales will be filled in by the intervention group by performing a progressive relaxation exercise.

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

Participants in this group will be given a gradual muscle relaxation exercise.

Exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteer to participate in the study,
  • Those who are 18 years of age and over,
  • Those who underwent coronary bypass graft surgery
  • Communication difficulties and mental disability regarding vision, hearing and speech non,
  • Blood pressure measurement does not need to be done on an outpatient basis,
  • Any postoperative complications (bleeding, nausea, vomiting, etc.) not occurring,
  • Analgesic medication should be administered before the first intervention planned to be performed after the surgery.
  • not implemented,
  • Any medication etc. without substance addiction,
  • Does not have chronic pain in any part of the body,
  • Those who were extubated after cardiac surgery and were not given sedating medication
  • All non-pregnant patients will be included in the sample.

You may not qualify if:

  • Any symptoms such as severe bleeding, nausea or vomiting after the surgical procedure.
  • developing complications,
  • Patient-controlled analgesia (PCA) for pain control after surgery applied
  • Those with deformity in the chest area,
  • Preoperative respiratory function test is not within normal limits,
  • Patients with Chronic Obstructive Pulmonary Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Özel Bilgi Hastanesi

Ankara, 06510, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersPain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled (experimental and control group)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registered nurse

Study Record Dates

First Submitted

April 30, 2024

First Posted

May 8, 2024

Study Start

October 18, 2023

Primary Completion

June 1, 2024

Study Completion

June 20, 2024

Last Updated

May 8, 2024

Record last verified: 2024-05

Locations