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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04100629
Other study ID # 2019/06/10
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date December 13, 2019
Est. completion date May 14, 2020

Study information

Verified date June 2020
Source Duquesne University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Brief Description of the Study: Text messages will be sent to participants and responses will be surveyed to ascertain if using a social, digital intervention can influence NLNs' (newly licensed nurses') stress, resiliency, perceived sense of social support, and/or the intention to stay at current jobs. Newly licensed nurses (within their first year of hire) will be asked to participate. A series of four text messages will be sent to all study participants (experimental and control groups) by the PI every Monday, Wednesday, Friday, and Saturday (M, W, F, S) at 1pm for six weeks, for a total of 24 different texts for each group. Participants will fill out surveys before the study begins, at week 3 and at the end of the study (week 6).The control group will receive medical facts. Texts sent to the experimental group will be based on SSBC nurturant support messages and are intended to decrease stress intention to leave (ITL), increase resilience, and perceived sense of support. The SSBC nurturant support texts are comprised of three themes of support: emotional, network, and esteem. The experimental group's supportive text messages were created by the PI and require content validation. A gatekeeper at your facility will be asked to send an email to "Experts" (MSN educators) and ask them to complete the validation survey using a Qualtrics Survey Platform then the PI will place ratings into a table and calculate the results. There are 3 other facilities enrolled in this study: University California, San Diego, El Centro Medical Center, and Pioneer Hospital (all located in southern California).


Description:

The purpose of this randomized control study (RCT) is to determine the impact of a 6-week digital support intervention (text messaging) on NLNs' levels of stress, resiliency, perceived social support, and ITL (intention to leave) their current jobs. The long-term objective is to examine if a 6-week digital support intervention impacts NLNs' (newly licensed nurses') ITL during the first year of hire. The central hypothesis is that a digital support intervention plays a critical role in NLNs' levels of stress, resilience, perceived sense of social support, and ITL their current jobs. In order to be included in this proposed study, participants must agree to not use their Smartphones while providing direct patient care but may access text messages while in designated break areas or when off duty.

Research Questions: RQ1: What is the effect of a digital support intervention upon NLNs' stress? RQ2: What is the effect of a digital support intervention upon NLNs' resiliency? RQ3: What is the effect of a digital support intervention upon NLNs' perceived social support? RQ4: What is the effect of a digital support intervention upon NLNs' ITL their first jobs during their first year of hire?

Design (Description of research plan, intervention(s) and time frame): A prospective, RCT design with an experimental and control group is proposed for this study to determine if a digital support intervention impacts NLNs' stress, resiliency, perceived sense of support, and Intention to Leave.


Recruitment information / eligibility

Status Terminated
Enrollment 23
Est. completion date May 14, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 37 Years
Eligibility Inclusion Criteria:

- Newly Licensed Nurses,

- ages 19-37 years,

- proficient in English,

- working in an acute care facility as a RN during the first year of hire,

- have a working personal Smartphone,

- have the ability to send and receive text messages,

- have an active and working personal email account, and

- be willing to participate for six weeks,

- complete a demographic survey before the study, survey instruments at 3 weeks, 6 weeks, and at the conclusion of the study

- agree to not use or carry their Smartphone while performing direct patient care and

- assume any data charges for text messages, if incurred.

Exclusion Criteria:

- Newly Licensed Nurses who have worked in the role of a RN on another floor or

- NLNs who have worked as an RN at another organization, or

- NLNs not 19-37 years of age.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
digital support: text messages
In this study, the text messages are intended to be one-directional, from the PI to the participant. Participants are not expected to reply. If participants reply to any of the text messages, the PI will screen the content and only reply if it is a question regarding the study or a request to seek counseling. Additionally, participants will be instructed by the PI to access their Smartphones to read texts while on a break, after their shift, or when not at work; participants will be instructed to not use Smartphones to read texts while working. A series of four text messages will be sent to all study participants (experimental and control groups) by the PI every Monday, Wednesday, Friday, and Saturday (M, W, F, S) at 1pm for six weeks, for a total of 24 different texts for each group.

Locations

Country Name City State
United States Pioneer Hospital Brawley California
United States El Centro Regional Medical Center El Centro California
United States Allegheny General Hospital Pittsburgh Pennsylvania
United States University of California, San Diego San Diego California

Sponsors (5)

Lead Sponsor Collaborator
Duquesne University El Centro Medical Center, Pioneers Hospital, University of California, San Diego, West Penn Allegheny Health System

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reported levels of perceived stress will change; predicted to decrease. The Perceived Stress Scale (PSS) will be used to measure stress (Cohen, Kamarck, & Mermelstein, 1983). Participant stress will measured prior to intervention, at 3 weeks, and 6 weeks. It is a 10-item, Likert-type scale with five points. Scores are obtained by using the item responses that range from 0 to 4 (0 = never, 1 = almost never, 2 = sometimes, 3 = fairly often, 4 = very often) with items 4, 5, 7, and 8 reversely scored. The summed scores of the PSS will be used for one of the dependent variables and will be discussed further as a key variable. Participants will be asked to think about their current work situation when answering survey questions. The possible range of scores, after adding all points, will range from 0 to 40, with higher scores signifying greater perceived stress. prior to intervention, 3 weeks, and 6 weeks
Primary Report levels of resiliency will change; predicted to increase. The Connor-Davidson Resiliency Scale (CD-RISC-25) will be used to measure resiliency (Connor & Davidson, 2003). Participant resilience will measured prior to intervention, at 3 weeks, and 6 weeks. The CD-RISC-25 is a 25-item self-report scale that uses a five-point Likert-type scale ranging from 0 (not true at all) to 4 (true nearly all the time). Total scores, ranging from 0-100, assess resilience and a score of 100 denotes the highest level of resiliency; the tool takes 5-10 minutes to complete (CD RISC, 2011). The summed scores of the CD-RISC 25 will be used for one of the dependent variables and will be discussed further as a key variable. prior to intervention, 3 weeks, and 6 weeks
Primary Reported levels of participants Sense of Support will change; predicted to increase. The Social Support Scale (SSS) will be used to measure perceived social support scores (Dolbier & Steinhardt, 2000). Participant perceived social support will measured prior to intervention, at 3 weeks, and 6 weeks. Respondents answer 21 items on a 4-option Likert-type scale labeled between 0 (not true at all) to 3 (completely true) (Dolbier & Steinhardt, 2000) and will take 20-25 minutes to complete (Versta, 2011). The summed scores of the SSS will be used for one of the dependent variables and will be discussed further as a key variable. prior to intervention, 3 weeks, and 6 weeks
Primary Intentions to Leave current job will change; predicted to decrease. An "Intention to Leave," investigator designed survey will be used to measure the participants' Intention to Leave their current jobs. Participant intention to leave their current job will measured at 6 weeks. Participants will be asked what percentage, if any, represents their ITL their current position and also what percentage represents their ITL to leave their current organization. 6 weeks
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