Study design and setting

A quasi-experimental research design was utilized in this study. It was conducted at the Cardiology Department, Alexandria Main University Hospital. The study was registered in the clinical trial.gov database (Clinicaltrials.gov NCT05887362, 23/05/2023). Available at: https://ichgcp.net/clinical-trials-registry/NCT05887362

Participants

The sample size was determined using the G*Power Windows 3.1.9.7 program, with the following criteria: effect size = 0.25, power (1-err prob) = 0.85, err α prob = 0.05, number of groups examined = 2, and the number of measurements = 3. Thus, the study group included 30 patients scheduled for CA, and the control group had an equal number. The inclusion criteria were patients between the ages of 20 and 60 who were scheduled for non-emergency CA, absence of any hands’ sensory motor disorders or upper limb vascular injuries, no abnormalities such as amputations, burns, skin lesions, and intervertebral disc herniation, and no history of mental illnesses.

As the diagram (Fig. 1) revealed, patients were selected from the cardiology department (N = 120) for reflexology sessions over four months. The number of patients excluded from the total assessed for eligibility (N = 53). Of them, 41 patients did not meet the inclusion criteria, six were excluded due to participation in the pilot study, and six refused to participate in reflexology sessions. Furthermore, seven patients withdrew prior to intervention due to the severity of their cardiac symptoms, the difficulty in contacting them for an interview, and their decision not to complete the sessions. All patients who took part in the study and control groups were treated as usual (TAU); the patients who were selected for the study group participated in reflexology sessions. All study and control groups completed the measurements after 2 h and three days after the intervention (N = 60).

Fig. 1

Flow chart for recruiting the study participants

Data collection tools

Four tools were used for collecting the data in this study:

Tool I: The socio-demographic and clinical data assessment sheet was created by the researcher to identify patients’ socio-demographic and clinical data, including their name, age, sex, marital status, level of education, occupation, area of residence, medical diagnosis, associated diseases, previous hospitalization and its reasons, history of smoking, previous history of CA, medications, and family history of CA.

Tool II: Visual Analogue Scale (VAS), developed by [19] to assess pain intensity. It is a 10 cm horizontal line with two ends; the left end typically denotes "no pain," while the right end typically denotes "worst possible pain." On the line, the patient was told to mark the location of the current pain. Score system: 0 represents "no pain," 1–3 "mild pain," 4–7 "moderate pain," 8–9 "severe pain," and 10 represents the "worst intractable suffering."

Tool III: The Rhoten Fatigue Scale (RFS) is a subjective rating scale developed by [20] to measure a patient’s fatigue level. It comprises a 10-cm line with highly positive and negative statements at either end. Scores ranged from 0 to 10 for positive and negative fatigue phrases. It is appropriate to interpret the scale's results as follows: 0 (no fatigue), 1–3 (mild), 4–6 (moderate), 7–9 (severe), and 10 (extreme fatigue).

Tool IV: The Beck Anxiety Inventory (BAI) was developed in 1988 by [21] to assess the severity of anxiety symptoms. The Likert scale for the 21 items that comprise the BAI ranges from 0 to 3. The overall score is between 0 and 63. The BAI scores are divided into four categories: minimal anxiety (0–7), mild anxiety (8–15), moderate anxiety (16–25), and severe anxiety (26 to 63)

Data collection and analysisAdministrative steps

The responsible authorities of the Faculty of Nursing, Alexandria University, including the Research Ethics Committee, were permitted to conduct this study. Official permission was received from the head of the Cardiology Department at the Main University Hospital after an explanation of the aim of the study.

Preparation phase

Tools II, III, and IV were translated into Arabic and reviewed by bilingual medical-surgical and psychiatric nursing experts. Also, a jury of five medical-surgical and psychiatric nursing experts was selected to test the face and content validity of the translated tools.

Pilot study and reliability

To test the clarity and applicability of the research tools, a pilot study including six patients, or 10% of the sample, was conducted. Modifications were made as necessary, such as "complications of previous angiography," which were omitted from tool I because patients could not answer this question and were not included in the patient's medical records. The clarity of other tools was ensured, especially after translation into Arabic. They were not included in the study's actual sample of participants. The study tools' internal consistency was assessed using Cronbach's alpha test. Tool II (= 0.824), Tool III (= 0.788), and Tool IV (= 0.868) were reliable.

Actual study

Patients’ medical charts in the department were reviewed to identify those who meet the inclusion criteria. Patients who met the predetermined inclusion criteria were recruited for the study through convenience sampling. Participants were divided into two equal groups (the control and the study groups). The researchers started by introducing themselves, explaining the purpose of the study, and then taking informed written consent from those who agreed to participate.

On the day of coronary angiography, after the CA procedure, and before implementing hand reflexology intervention for the study group, all patients in the control and study groups were interviewed individually to identify their socio-demographic and clinical data using Tool I and to assess their level of pain, fatigue, and anxiety using Tools II, III, and IV.

The control group was selected first and received the routine care delivered by the hospital, such as assessment of vital signs, supine position, complete bed rest, and hygienic care. They didn’t receive the hand reflexology intervention.