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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05721339
Other study ID # IRB00013620-50-9-2022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date January 15, 2023

Study information

Verified date February 2023
Source Alexandria University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Work and family are the two most influential aspects of a person's life. The conflict between work and family can adversely affect an organization's and an individual's health and well-being. Research is necessary to describe, understand, and address work-family conflict because it arises from how people perceive it. Studies on social adjustment for healthcare staff and nursing interns are scarce in Egypt, according to researchers. Recently, ACT has been utilized to treat various psychological issues and challenges at work, among others. Therefore, the present study aimed to evaluate the impact of virtual group-based acceptance and commitment therapy on intern nurses' social adjustment and work-family conflict. Research Hypothesizes Intern nurses who engaged in a virtual group-based acceptance and commitment therapy will exhibit lower level of family-work conflict than the control group. Intern nurses who engaged in a virtual group-based acceptance and commitment therapy will exhibit a higher level of social adjustment than the control group.


Description:

Given the nature of the nursing profession, intern-nurses frequently interact with patients, their families, physicians, and all levels of hospital administration. Time, long-term work, shifting hours, sleeplessness, death observation, cancer, high healthcare demands, and a low tolerance for incompetence are all sources of stress for those newly graduate nurses. As a result, their social adjustment significantly affects whether they are able to remain motivated and collaborative. Work conflict has become a type of intra-role conflict in which both parties' work and family responsibilities overlap. This term applies to the unfavorable interaction that exists between work and family when there is a discrepancy between reality and expectations, which disrupts and affects job performance at work or at home. Intern nurses was trained in the Main University Hospital (El-Miri), University Hospital Smouha, El Shatby Hospital for Obstetricians and Gynecologists, and El Hadara Orthopedic and Traumatology University hospital this study will be conducted. These hospitals were affiliated to Alexandria University for clinical training of intern-nurses in all nursing disciplines for around 12 months, beginning in September 2022 and ending in August 2023.According to the records of the internship candidates' affairs department and internship coordinator at the Faculty of Nursing, the total number of enrolled candidates during this academic year was 800 candidates. G*Power Windows 3.1.9.7 a program with the following parameters was used to estimate the participants: Power (1-β err prob) =.88, effect size =.5, α err prob = .05. The program identified a minimum sample size of 34 intern nurses for each group. Thus, the sample will be comprised of 70 intern nurses, the study group will compose of n = 35 participants, the control group will be the same number. A representative sample of intern nurses will be allocated to either the study or control groups using the random assignment technique. "Implementation phase": Seventy intern-nurses will be selected at random to assign the study or control group, the researchers will attempt to match the control group as accurately as possible in terms of age, gender, marital status, and working hours' duration. Then, those participants will meet individually in a private online meeting to create rapport, discuss the goal of the study and the therapy that will be employed, and obtain their written consent. The pretest phase will begin with the collection of baseline assessment data from the study and control groups on the study instruments II, III, and IV, utilizing computerized forms. The intervention phase will start with the study group being randomly will be divided into five small groups, each having six ACT participants. For three weeks, the ACT sessions will be held twice a week for 90 minutes each. Each session will be conducted by two researchers, one as a leader to explain the fundamental core of the therapy for about 60 minutes and the other as a mediator to organize homework assignments with the participants and answer any queries for about 30 minutes. Evaluation or Follow-up Phase." The last phase, "the posttest," will be done twice immediately following the end of all sessions, as well as a one-month later as a follow-up utilizing tools II, III and V.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date January 15, 2023
Est. primary completion date November 1, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - The beginner intern nurses at the academic year 2022-2023. - Single candidates. - Willing to participate in the study. Exclusion Criteria: - Intern nurses who diagnosed with any chronic medical diseases. - Intern nurses who diagnosed with any mental illnesses.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Acceptance and Commitment Therapy
ACT will be applied through 8 sessions by the psychological flexibility processes, which were grouped into three response styles: open, aware, and active. Openness is reflected by acceptance, which means the conscious embrace of psychological events without unnecessary attempts to change their frequency. Defusion means untangling unhelpful thoughts and responding to mental experiences as experiences rather than guides to action. The awareness set, which is reflected by applying self-as-context, which means a continuous and secure "I" from which events are experienced but distinct from those events. A present moment means ongoing, nonjudgmental contact with internal and external events as they occur in the present moment. The active set, which was reflected by making the intern nurses embrace their desired and chosen life values directions, and commit action to selected values.

Locations

Country Name City State
Egypt Faculty of Nursing Alexandria

Sponsors (1)

Lead Sponsor Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

AlAzzam M, AbuAlRub RF, Nazzal AH. The Relationship Between Work-Family Conflict and Job Satisfaction Among Hospital Nurses. Nurs Forum. 2017 Oct;52(4):278-288. doi: 10.1111/nuf.12199. Epub 2017 Apr 13. — View Citation

Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther. 2006 Jan;44(1):1-25. doi: 10.1016/j.brat.2005.06.006. — View Citation

Prudenzi A, Graham CD, Flaxman PE, Wilding S, Day F, O'Connor DB. A workplace Acceptance and Commitment Therapy (ACT) intervention for improving healthcare staff psychological distress: A randomised controlled trial. PLoS One. 2022 Apr 20;17(4):e0266357. doi: 10.1371/journal.pone.0266357. eCollection 2022. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The Work-related Acceptance and Action Questionnaire It was developed to assess psychological flexibility in professional contexts. It consists of seven statements assessed on a Likert Scale from 1 (Never true) to 7 (Always true), such as "I can admit my faults at work and yet be successful," and "I can work efficiently even when I doubt myself." The items stand for people's ability to take goal-directed action in the face of unpleasant internal experiences. The Work-related Acceptance and Action Questionnaire scores range from 7 to 49, with higher scores suggesting greater psychological flexibility. up to 14 weeks
Primary The Social Adjustment Scale-Self Report The Social Adjustment Scale-Self Report is a popular 54-items self-reported social adjustment scale that assesses instrumental and expressive role performance over the previous two weeks. It addresses six areas of functioning: employment (as a paid worker, unpaid homemaker, or student), social and leisure activities, interactions with extended family, marital partner role, parenting role, and role within the family unit.The elements in each of the six categories encompass four sorts of content: performance at anticipated tasks, interpersonal friction, finer characteristics of interpersonal relationships, and emotions and satisfactions. The full-length Social Adjustment Scale-Self Report takes around 15-20 minutes to administer.The higher the score of Social Adjustment Scale-Self Report, the more impairment in social adjustment. up to 14 weeks
Primary Work-Family Conflict Scale Work-family conflict and family-work conflict were divided on the scale. Each subscale comprised five items that measured the level of conflict in that subscale. It is evaluated on a 7-point Likert scale, with 1 being "very strongly disagree" and 7 being "very strongly agree". The items for each subscale are totaled to supply the overall scores of Work-Family Conflict Scale (ranging from 7 to 35) and Family-Work Conflict Scale (ranging from 7 to 35); higher scores show higher degrees of conflict. up to 14 weeks
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