Nurse's RoleNCT05721339
Virtual Acceptance and Commitment Therapy Impact on Social Adjustment and Work-Family Conflict Among Intern Nurses
A study testing Acceptance and Commitment Therapy in people with Nurse's Role, run by Alexandria University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nurse's Role
- What is being tested?
- Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 15 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The beginner intern nurses at the academic year 2022-2023.
- Single candidates.
- Willing to participate in the study.
Who cannot join
- Intern nurses who diagnosed with any chronic medical diseases.
- Intern nurses who diagnosed with any mental illnesses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Virtual Group-Based Acceptance and Commitment Therapy on Social Adjustment and Work-Family Conflict Among Intern Nurses: A Randomized Control Trial
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.
Read the detailed 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.
- Conditions
- Nurse's Role
- Being tested
- Acceptance and Commitment Therapy
- Keywords
- Acceptance and Commitment Therapy, Intern Nurses, Social Adjustment, Work-Family Conflict
- Medical subject headings
- Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
Also called functional contextualism
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.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance and commitment therapy | Experimental | Intern nurses will participate in acceptance and commitment therapy through virtual group-based eight sessions twice weekly with homework assignments between sessions and skills demonstration. Receives: Behavioral: Acceptance and Commitment Therapy |
| control group | No intervention | Intern nurses who will not participate in acceptance and commitment therapy. And they are undergoing the pre-and post-tests and the post-test follow-up test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 14 weeks
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.
Measured: up to 14 weeks
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.
Measured: up to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start1 Sep 2022
- Primary completion1 Nov 2022
- Study completion15 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Nurse's RoleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ayman el-ashry, Alexandria University
- Investigators
- Ayman M El-Ashry, PHD, Principal investigator, Faculty of nursing, Alexandria University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05721339
- Sponsor's protocol ID
- IRB00013620-50-9-2022
- Status last verified
- Feb 2023
- First submitted
- 31 Jan 2023
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35442963Hayes 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.
PubMed 16300724AlAzzam 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.
PubMed 28407250El-Ashry AM, Elhay ESA, Taha SM, Salem ESAEHES, El-Sayed MM. Impact of virtual group-based acceptance and commitment therapy on social adjustment and work-family conflict among intern nurses: a randomized control trial. BMC Psychiatry. 2023 Aug 1;23(1):552. doi: 10.1186/s12888-023-05045-8.
PubMed 37525125
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Virtual Group-Based Acceptance and Commitment Therapy on Social Adjustment and Work-Family Conflict Among Intern Nurses: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05721339
- Acronym / sponsor ID
- IRB00013620-50-9-2022
- Conditions
- Nurse's Role
- Keywords
- Acceptance and Commitment Therapy, Intern Nurses, Social Adjustment, Work-Family Conflict
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 15 Jan 2023 (actual)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acceptance and commitment therapy | Experimental | Behavioral: Acceptance and Commitment TherapyIntern nurses will participate in acceptance and commitment therapy through virtual group-based eight sessions twice weekly with homework assignments between sessions and skills demonstration. |
| control group | No intervention | –Intern nurses who will not participate in acceptance and commitment therapy. And they are undergoing the pre-and post-tests and the post-test follow-up test. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- The beginner intern nurses at the academic year 2022-2023.
- Single candidates.
- Willing to participate in the study.
Key exclusion criteria (2 listed)
- Intern nurses who diagnosed with any chronic medical diseases.
- Intern nurses who diagnosed with any mental illnesses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment TherapyAlso: functional contextualismACT 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. | Behavioural | Acceptance and commitment therapy |
Primary outcome
The Work-related Acceptance and Action Questionnaire
Time frame: up to 14 weeks
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.
The Social Adjustment Scale-Self Report
Time frame: up to 14 weeks
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.
Work-Family Conflict Scale
Time frame: up to 14 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2023.
- Background: PubMed 35442963Prudenzi 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.
- Background: PubMed 16300724Hayes 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.
- Background: PubMed 28407250AlAzzam 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.
- Derived from this study: PubMed 37525125El-Ashry AM, Elhay ESA, Taha SM, Salem ESAEHES, El-Sayed MM. Impact of virtual group-based acceptance and commitment therapy on social adjustment and work-family conflict among intern nurses: a randomized control trial. BMC Psychiatry. 2023 Aug 1;23(1):552. doi: 10.1186/s12888-023-05045-8.
- a worldwide online learning and research community, and a living resource for anyone interested in Acceptance and commitment therapy and Contextual Behavioral Science.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayman M El-Ashry, PHD principal investigator
Faculty of nursing, Alexandria University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy in people with Nurse's Role, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Work-related Acceptance and Action Questionnaire (time frame: up to 14 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05721339, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2023.