3.1. Research Hypotheses
3.1.1. Hypothesis Concerning Social Support
Main hypothesis: Perceived social support will have a significant negative correlation with lower levels of psychological distress (stress, anxiety, and depression). o Secondary Hypotheses: Social support is expected to be associated with less stress. Social support is expected to be associated with fewer anxiety symptoms. Social support is expected to be associated with fewer depressive symptoms.
3.1.2. Hypothesis concerning Spiritual Experiences
Main hypothesis: Daily spiritual experiences will have a significant negative correlation with lower levels of psychological distress (stress, anxiety, and depression). Secondary hypotheses: Daily spiritual experiences are expected to be associated with less stress. Daily spiritual experiences are expected to be associated with fewer anxiety symptoms. Daily spiritual experiences are expected to be associated with fewer depressive symptoms.
3.2. Study Design and Participants
This study employed a cross-sectional correlational design. A power analysis was conducted using G*Power software (version 3.1) to determine the minimum required sample size. With an anticipated medium effect size (f² = 0.15), an alpha of 0.05, and a power of 0.80 for a multiple regression analysis with three predictors, the analysis indicated a required sample size of 77 participants. To account for potential attrition and missing data, the sample was increased to 100 breast cancer patients. Participants were recruited through a convenience sampling approach from the chemotherapy department at Khatam Al-Anbia Hospital in Zahedan, Iran, in 2024 - 2025.
3.3. Ethical Considerations and Data Collection Procedure
This study was approved by Zahedan University of Medical Sciences with the ethics code IR.ZBMU.REC.1403.013. All participants in this study were conscious, clinically stable, and decisionally capable patients who were cognitively able to understand the nature of the research and provide personal informed consent.
The informed consent procedure was as follows:
- Consent method: Written informed consent was obtained from all participants. A consent form detailing the study's aims, procedures, potential benefits and risks, the right to withdraw at any time, and guarantees of confidentiality was provided to the participants.
- Procedure for illiterate participants: For participants who were unable to read and write, the entire content of the consent form was read aloud to them. After ensuring their full comprehension, consent was obtained via thumbprint from the participant and the signature of an impartial witness.
- Confidentiality: Participants were assured that all their information would be kept strictly confidential. Data would be used in anonymized and aggregated form for analysis, and no personally identifiable information would be published in any resulting reports or articles.
- Recruitment: Eligible patients were invited to participate orally and via the information sheet, following confirmation of their clinical eligibility by their treating physician.
The data collection process was then initiated. The research team, comprising trained interviewers, conducted visits to the chemotherapy clinic.
- Interviewer training: To ensure reliable and truthful responses, all data collectors received standardized training. This training covered the study's objectives, the ethical necessity of voluntary participation and anonymity, and a standardized protocol for administering the questionnaires. Interviewers were instructed to read the questions neutrally, avoid interpreting items for participants, and create a private and comfortable environment to minimize social desirability bias.
Eligible patients who satisfied the study's inclusion criteria were invited to participate. The inclusion criteria were: (1) Female patients aged 30 to 70 years; (2) a confirmed pathological diagnosis of breast cancer; (3) minimum literacy skills required to complete the self-report questionnaires; (4) awareness of their diagnosis and provision of informed consent to participate; (5) physically and mentally stable enough to participate in the study, as determined by their treating physician or the research team.
3.4. Exclusion Criteria
A history of formal academic education or training in religious sciences, mysticism, or related fields (e.g., graduation from a seminary or holding a university degree in these disciplines) (This criterion was implemented to reduce the potential bias associated with specialized knowledge when responding to spirituality-related items and to create a more homogeneous sample in terms of theoretical knowledge about spiritual concepts.). The presence of any major psychiatric disorder or cognitive impairment (e.g., dementia), documented in the medical record or by the treating physician, that would seriously compromise the ability to understand and respond to the questionnaires. Severe clinical deterioration or end-stage disease that would make participation impossible (This criterion was assessed based on a review of the patient's medical records and, if necessary, consultation with their treating physician at the time of data collection.).
3.5. Handling of Missing Questionnaires
A proactive approach was taken to manage incomplete data. Questionnaires were checked for completeness on-site immediately after completion. If any items were missed, the participant was politely asked whether they would be willing to complete them. Questionnaires with more than 10% missing data on any scale were considered invalid and excluded from the final analysis, as per the exclusion criteria.
3.6. Instruments and Measures
Four standardized instruments were administered to gather research data. A key limitation to acknowledge is that the primary constructs of interest — spirituality, social support, and psychological distress — were measured using self-report instruments, which are susceptible to biases such as social desirability and recall bias.
3.6.1. Demographic and Clinical Questionnaire
A researcher-developed questionnaire collected information on age, marital status, occupation, income, educational attainment, cancer duration, hospitalization history, and chronic illness background.
3.6.2. The Daily Spiritual Experiences Scale
- Version & Source: The validated Persian version by Jafari et al. (
30) was used.
- Scoring & Interpretation: The scale consists of 16 items. Items are rated on a 6-point Likert scale (ranging from 1 = Never or almost never to 6 = Many times a day). The total score is calculated by summing the responses to all items, resulting in a possible range of 16 to 96. A higher total score indicates a higher frequency of daily spiritual experiences. o Reliability in this sample: The internal consistency for the Daily Spiritual Experiences Scale (DSES) in the present study was excellent, with a Cronbach's alpha of 0.94.
3.6.3. The Multidimensional Scale of Perceived Social Support
- Version & Source: The validated Persian version of the Multidimensional Scale of Perceived Social Support (MSPSS) (
31) was used.
- Scoring & Interpretation: This 12-item scale is rated on a 7-point Likert scale (from 1 = Very strongly disagree to 7 = Very strongly agree). The total score is the sum of all 12 items (range: 12 - 84). A higher total score indicates a higher level of perceived social support. The scale can also be interpreted based on its three subscales: Family, friends, and significant other.
- Reliability in this sample: The MSPSS demonstrated high internal consistency in this study, with a Cronbach's alpha of 0.91 for the total score.
3.6.4. The Depression, Anxiety, and Stress Scale-21 Items
- Version & Source: The validated Persian version of the Depression, Anxiety, and Stress Scale - 21 Items (DASS-21) (
32) was used.
- Scoring & Interpretation: The DASS-21 has 21 items, rated on a 4-point severity scale (from 0 = Did not apply to me at all to 3 = Applied to me very much, or most of the time). The scores for the Depression, Anxiety, and Stress subscales are calculated by summing the scores for the respective 7 items and then multiplying the sum by 2. This converts the score to be comparable to the full 42-item DASS. The resulting subscale scores are interpreted using the standard severity cut-offs shown below (
Table 1).
| Severity | Depression | Anxiety | Stress |
|---|
| Normal | 0 - 9 | 0 - 7 | 0 - 14 |
| Mild | 10 - 13 | 8 - 9 | 15 - 18 |
| Moderate | 14 - 20 | 10 - 14 | 19 - 25 |
| Severe | 21 - 27 | 15 - 19 | 26 - 33 |
| Extremely Severe | 28+ | 20+ | 34+ |
The scores from the three DASS-21 subscales (depression, anxiety, and stress) were summed to create a single composite score representing overall psychological distress. This approach was chosen because the subscales were highly intercorrelated in our sample (Cronbach's alpha = 0.92 for the total scale), justifying their combination into a global measure of negative emotionality. Consequently, all subsequent analyses were performed using this composite score.
3.7. Data Analysis
Statistical analysis was performed using SPSS Statistics (version 24). Descriptive statistics (frequencies, means, standard deviations) were used to characterize the sample. To assess the assumption of normality for the key continuous data (scores of spiritual experiences, social support, depression, anxiety, and stress), the Shapiro-Wilk test of normality was conducted. The results of this test indicated that the data distribution for all these variables significantly deviated from normality (P < 0.05 for all variables). Furthermore, visual inspection of histograms and Q-Q plots confirmed this departure from normality. Additionally, data from psychometric scales are often measured at an ordinal level. Considering these factors and the non-parametric nature of the data, Spearman's rank-order correlation was selected as the appropriate method for examining the relationships between variables. In addition to correlation coefficients, effect sizes will be reported for all significant findings to provide a measure of their practical significance.
A Bonferroni correction for multiple comparisons was not applied. This decision was made because the analysis was primarily exploratory in nature, aiming to identify potential relationships for future research without overly increasing the risk of Type II errors (failing to identify true effects). The interpretation of results focused on the effect sizes and patterns of relationships, with a recognition of the increased family-wise error rate. All P-values are reported uncorrected to allow for transparent evaluation.
To examine the unique contribution of the main study variables in predicting psychological distress and to control for potential confounding factors, a hierarchical multiple linear regression analysis was conducted. The composite psychological distress score was entered as the dependent variable. Predictor variables were entered in two blocks: The first block included demographic and clinical covariates (age, education level, income, and symptom burden), and the second block included the main study variables (social support and daily spiritual experiences).