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Development and Assessment of the Reliability and Validity of a Psychological Stress Scale for Catheterized Home Healthcare Patients

Background: Accidental dislodgement of tubes/catheters from patients’ bodies is frequent in healthcare; making it a crucial patient safety management issue. Additionally, the number of patients needing catheter management at home has increased with the rise in aging patients. Pain or stress from directly inserting a tube/catheter into the body causes accidental dislodgement. However, quantitative measurements have not yet been developed to evaluate patients’ stress resulting from dislodgement fear. Aim: This study aimed to develop a psychological stress scale for patients using tubes/catheters at home (PSS-CP) and evaluate its reliability and validity. Materials and Methods: The questionnaire was developed through interviews with 10 patients using tubes/catheters at home. Reliability was examined using the test-retest method and Cronbach’s α. J Pharm Pharmacol Res 2022; 6 (1): 1-14 DOI: 10.26502/fjppr.047 Journal of Pharmacy and Pharmacology Research Vol. 6 No. 1 March 2022. 2 Factorial and criterion-related validity were examined using exploratory factor analysis and the 12-item General Health Questionnaire, respectively. Results: The PSS-CP comprised 16 items across four factors: “anxiety about catheter dislodgement while moving or in the toilet,” “anxiety about tube dislodgement when resting or lying down,” “anxiety about tube dislodgement while dressing/undressing,” and “anxiety about tube dislodgement while bathing.” Criterion-related validity was significantly correlated with general anxiety (r = 0.71, p < 0.01) and pain/discomfort (r = 0.364, p < 0.05). The retest method showed a highly significant correlation (r = 0.791, p < 0.01), with Cronbach’s α > .90. Conclusions: A scale to measure psychological stress among catheterized home healthcare patients was developed and its reliability and validity demonstrated.


Introduction
Accidental dislodgement of tubes/catheters from patients' bodies frequently occurs in healthcare settings [1,2]. Such dislodgements, other than endangering the patient's life, entail high costs for both patients and healthcare professionals alike, resulting in problems such as disruption of targeted drugs and nutritional delivery, persistence of foreign substances, pain/insertion error/injury at reinsertion, increased strain on labor resources, and elevated economic costs. Hence, the prevention of accidental dislodgements has emerged as a crucial issue in patient safety management.
Considering this clinical issue, hospitals have increasingly adopted countermeasures, including the use of more firmly secured tubes/catheters and physical restraints on patients [3]. According  self-dislodgement and 126 spontaneously dislodged tubes/catheters [4]. Furthermore, existing data attribute the highest incidence of accidental tube/catheter dislo-dgement to acute geriatric hospitals [5], signifying that such accidental dislodgements still remain an unaddressed problem.
Meanwhile, with the progression of home healthcare systems, the number of patients needing catheter management at home is increasing. Tubes and catheters play an essential role in home healthcare and have been used to administer injectable narcotics in terminally ill cancer patients [6,7], provide central venous and enteral nutrition in patients undergoing nutrition management [8,9], and for many other purposes. This trend has unfortunately been accompanied by numerous incidents wherein a tube or catheter, such as a feeding tube, becomes dislodged in a home healthcare setting [10].

Data collection
The PSS-CP was developed after conducting semi- Considering Japanese people's tendency to select a middle response alternative [20], we decided to avoid odd numbers of responses and used a six-point scale: "I don't think so at all: 1 point"; "I don't think so: 2 points"; "Somewhat disagree: 3 points"; "Somewhat agree: 4 points"; "I think so: 5 points"; "I totally agree: 6 points."

Subjects
Patients using the following tubes and catheters at home were included in the study: intravenous  However, if it was not filled out, it was determined that consent was not obtained.

Questionnaire items
In addition to the questionnaire items included in the PSS-CP, sociodemographic data was collected, including age, gender, duration of using home healthcare, duration of using tubes/catheters at home, and history of tubes/catheters removal.

Data Analysis
To account for differences in prognosis, the analysis was stratified into cancer and non-cancer patients.

Content Validity
Preliminary tube/catheter-related stress items were screened for inappropriateness by an expert committee consisting of five experts from each of the following fields: physicians specializing in medical safety, home health care physicians, home health care nurses, medical safety researchers, medical safety management pharmacists, scale development researchers, psychiatric nurse researchers, and administrative staff (statisticians). The experts gathered to discuss, confirm, and revise each item's content after factor analysis.

Factorial Validity
An exploratory factor analysis (principal factor analysis, Promax rotation) was performed to determine the factor structure of the PSS-CP.
Following the factor analysis, items with a factor load of 0.5 or higher were selected to reduce the number of questions.

Criterion-Related Validity
The GHQ-12, a concise version of the General Health Questionnaire (GHQ), was used to evaluate the criterion-related validity. Developed by Goldberg [19], it is used to assess one's mental health and is an effective screening tool for identifying mental disorders. A Japanese version of the GHQ-12 was developed by Nakagawa and Daibo [20], and its reliability and validity have been verified by Niiro and Mori [21].
To investigate the relationship between the number of catheters and stress, the total PSS-CP score was calculated for each participant's number of catheters inserted and compared using a t-test.

Reliability Testing
The internal consistency (Cronbach's α coefficient) and the test-retest method were utilized for reliability testing. SPSS Ver. 28 for Windows was used for the analysis. The retest was conducted during the period from one week (lower limit) to several months (upper limit) following the first test [22].

Ethical Considerations
The study's purpose, research plan, methodology, privacy protection policy, transparency of research outcomes, and any vested interests or conflicts of interest due to research collaborations were explained to the participants before their consent for participation was sought. We requested patients to cooperate only after their consent was received. This study was approved by the relevant institutional ethics committee (approval no. 2017-0111-2).

Patient Background
Of the 87 survey forms distributed, 47 responses were received (54.02% response rate). Of these, 44 (93.6%) were deemed valid. Three invalid questionnaires were excluded: two because the respondent's age was unclear and one because the majority of questions were unanswered.  Others c 3 (37.5) 5 (13.9) 0.145 a As multiple tube/catheter types may be inserted in each patient, the total ratio may exceed 100%. b IVH: Intravenous Hyperalimentation c Others: There were two cases each of nephrostomy tubes, peripheral venous catheters, and enterostomy tubes, and one using an indwelling bladder catheter with a balloon.

Content Validity Testing
Seven screeners (one patient safety specialist physician, one home healthcare physician, one pharmacist, one patient safety researcher, one homevisit nurse, one psychiatric nursing researcher, and one administrative clerk who did statistical analyses) scrutinized questions for the scale measuring tube/catheter-related stress and determined that no further revisions were necessary.

Factorial Validity Testing
Four factors were derived from the factor analysis (Table 2)   The fourth factor comprised two items with high factor loadings: Q13 "Because of the tube, I find it difficult to take a bath," and Q15 "Sometimes I skip bathing because of the tube." Based on these items, the factor was labeled "Anxiety about tube dislodgement while bathing."

Criterion-Related Validity Testing
For the criterion-related validity testing, Pearson's product moment correlation coefficients with GHQ-12, which measured the generalized anxiety, were calculated for the four factors of PSS-CP (Table 3).
Regarding tube/catheter-related generalized anxiety, correlations were found for each factor, as follows:    (Table 4).

Reliability Testing
For reliability testing, an internal consistency analysis (Cronbach's α coefficient) was performed ( Table 3).
The coefficients for the first, second, third, and fourth factors were 0.946, 0.92, 0.878, and 0.796, respectively. The coefficient derived for the entire scale was 0.943. The test-retest method indicated a highly significant correlation (r = 0.791, p < 0.01).

Discussion
The purpose of this study was to develop a stress scale for patients using tubing catheters. Importantly, stress were identified, covering items such as psychological and physical distress in daily life activities.
The sixth items in the first factor (i.e., "anxiety about catheter dislodgement while moving or in the toilet") allude to the basic human needs of "eliminating body wastes" and "moving the body's position and maintaining body postures (movements)," as indicated in Henderson's need theory [23]. When humans attempting to satisfy those needs face obstructions or inconvenience, they become highly stressed. Particularly, in terms of mobility, when certain behaviors (movements) are restricted to a certain degree due to tubes/catheters, such limitations become, in a sense, quasi-physical restraints.
Physically restrained humans are reportedly prone to psychological reactions such as anger, anxiety, and fear [24]. Hence, it can be inferred that catheterized patients likely experience similar feelings and are thereby subject to stress. Therefore, we believe that the second factor is strongly correlated with the item on "general anxiety" about tubing and catheters because of a sense of restraint. Further, psychological influences may also be observed in the high correlation of the current scale with the GHQ-12.
In the fourth item of the second factor (i.  [28]. When organ injury or inflammation is accompanied by pain, it is believed that psychological stress co-occurs with physical stress [29]. Therefore, it can be inferred that dermatological and similar disorders induced by catheterization entail both psychological and physical pain. This is the reason for the strong correlation with "general anxiety" about the tube and with GHQ-12 scores.
The fourth factor, "anxiety about catheter dislodgement while bathing," consists of two items.
As one of the basic human needs cited by Henderson [23], bathing has also been reported to be efficacious in bringing about mental relaxation that assuages bodily fatigue [30]. When a person is prevented from bathing by some particular impediment, stress arises.

Conclusions and Relevance
This study attempted to construct a PSS-CP, culminating in a four-factor scale whose reliability and validity were both duly corroborated. A factor