The Effect of Foot Massage After Open Heart Surgery on Postoperative Pain, Sleep Quality and Mood of Patients

NCT05567107 | Completed

• 1 other identifier: BKiziloglu
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The randomized controlled experimental study was conducted in the cardiovascular surgery clinic of Atatürk University Health Practice and Research Center between April 2021 and September 2021.The research sample consisted of 91 patients who met the research criteria. Since exclusion criteria were met in 15 patients during the research process, the study was completed with 76 patients. Descriptive Information Form, Visual Analog Scale, State-Trait Anxiety Scale, Visual Analog Sleep Scale and Hospital Anxiety and Depression Scale were used as data collection tools. All scales were applied to the patients preoperatively. According to the Postoperative Visual Analog Scale, the patients in the experimental group who stated that they had more than 4 pains were given foot massage for a total of 20 minutes, 10 minutes on each foot. After the surgery, classical foot massage was applied to the patients for 3 consecutive days, including the day they came to the service from the intensive care unit. One day after each application, the patients' pain, sleep quality and mood levels were examined. Data were collected by applying the same procedure steps without foot massage to the patients in the control group.

Conditions

Pain, Postoperative; Sleep Disturbance; Mood; Bypass Complication

Keywords

sleep quality; open heart surgery; foot massage; pain; mood

Outcome Measures

Primary Outcomes (4)

• Visual analog scale

  The visual analog scale was used to evaluate the pain severity of the patient. It is a self-reported scale in the form of a 10-cm ruler indicating no pain at one end and unbearable pain at the other. Accordingly, the patient is told to evaluate his/her pain between 0 and 10, with 0 cm indicating "no pain" and 10 cm indicating "unbearable pain"

  [Time Frame: up to 24 hours]

• State-Trait Anxiety İnventory (STAI-I, STAI-II)

  It is a test developed by Spielberger et al. that measures state and trait anxiety levels. Its validity and reliability in Turkey was done by O#ner and Le Compte. The scale consists of two parts, the 'state anxiety scale', which is created with the aim of determining the instantaneous feelings, and the 20-item 'trait anxiety scale', which was created to determine the feelings in general. It is a four degree scale ranging from 'Nothing' to 'All'. Scores range from 20 (low anxiety) to 80 (high anxiety).

  [Time Frame: up to 24 hours]

• Visual Comparison Sleep Scale

  Scoring in this scale, whose Turkish version consists of 10 items, was formed by reversing the 2nd, 4th, 8th and 9th statements. Each item in the scale was evaluated by visual comparison technique by showing it on the chart between 0 (on the left end) and 100 (on the right end). The score obtained from the scale is between 0-1000. An increase in the score obtained from the scale indicates a decrease in sleep quality.

  [Time Frame: up to 24 hours]

• Hospital Anxiety and Depression Scale

  It consists of two subscales, depression and anxiety. Each subscale includes 7 items. There are 14 items in total. While summing the scores of items 1, 3, 5, 7, 9, 11 and 13 for the Anxiety Subscale of the Hospital Anxiety and Depression Scale; For the Depression Sub-Scale, the scores of items 2, 4, 6, 8, 10, 12 and 14 are added. Items 3, 5, 6, 8, 10, 11, and 13 of the Anxiety Sub-Scale of the Hospital Anxiety and Depression Scale show gradually decreasing severity and are scored in a 4-point Likert scale as 3, 2, 1, 0. Items 2, 4, 7, 9, 12 and 14 of the Depression Subscale of the Hospital Anxiety and Depression Scale show increasing severity and are scored as 0, 1, 2, 3 on a 4-point Likert scale. The lowest score that patients can get from the Anxiety and Depression Subscales is 0, and the highest score is 21.

  [Time Frame: up to 24 hours]

Study Arms (2)

experimental group: applied foot massage

EXPERIMENTAL

Scales were applied preoperative to the patients. After being discharged from the intensive care unit in the postoperative period, the scales were applied without any intervention on the first day of hospitalization (day 0). Pain intensity was evaluated according to the Visual Comparison Pain Scale and classical foot massage was applied to patients who stated that they had 4 or more pain. After leaving the intensive care unit in the postoperative period, the scales were applied on the 2nd day (day 1) when the patient came to the service. After the scales, foot massage was applied again. After leaving the intensive care unit in the postoperative period, the scales were applied on the third day (day 2) when the patient came to the service. After the scales, foot massage was applied again. After the patient was discharged from the intensive care unit in the postoperative period, the scales were applied on the fourth day (3rd day) when they came to the service.

Other: massage

control group: unapplied foot massage

NO INTERVENTION

Each data collection tool was collected without applying foot massage, as in the experimental group patients. While the patients in the control group received only analgesic treatment postoperatively, the patients in the experimental group received foot massage in addition to the analgesic treatment. Only routine nursing care was given to the patients in the control group postoperatively.

Interventions

massage OTHER

Classical foot massage was applied by the researcher with efflorescence, superficial friction and petrissage techniques for 10 minutes on each foot.

experimental group: applied foot massage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those who agree to participate in the research
• Those who have planned coronary artery bypass graft surgery between the specified dates
• years of age or older
• Not having visual/verbal/auditory communication difficulties and mental disabilities that would prevent him/her from expressing the explained information correctly.
• Hypertension under control
• Those who state that they have 4 or more post-operative GCS pain
• For patients in the experimental group; infectious disease of the foot skin, local infection, open lesion/wound, scar tissue, edema, hematoma, thrombophlebitis, deep vein thrombosis, coagulation disorder, varicose veins, osteoporosis, osteomyelitis, hepatitis, inflammatory and degenerative joint diseases, diabetes-induced neuropathy, toes patients without deformities, recent fractures, dislocations, ruptures of muscle fibers, tendons, or fascia

You may not qualify if:

• ◾Patients who develop any complications after surgery

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Beyzanur Kızıloğlu

Erzurum, Palandöken, 25000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Parasomnias; Sleep Initiation and Maintenance Disorders; Pain

Interventions

Massage

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: October 5, 2022
• Study Start: June 5, 2020
• Primary Completion: April 10, 2021
• Study Completion: September 10, 2021
• Last Updated: October 5, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)