Trial Outcomes & Findings for Effect of Nurse-led Education on Parent's Anxiety and Depression on Managing Side Effects of Chemotherapy (NCT NCT03753542)
NCT ID: NCT03753542
Last Updated: 2022-07-28
Results Overview
DASS-21 is comprised of questionnaires for three separate scales measuring Depression, Anxiety and Stress. The depression scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 28+, with higher scores indicating greater severity. The anxiety scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 20+, with higher scores indicating greater severity. The stress scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 37+, with higher scores indicating greater severity
COMPLETED
NA
100 participants
up to 4 weeks
2022-07-28
Participant Flow
The parents along with children were recruited in the study from September 2018 to November 2018 and follow up were continued from October 2018 to December 2018. After the completion of follow up to 5th December 2018 the trail was ended due to the completion of target sample sized (N=100) of parents and follow up schedule.The age of children were taken as associated factor for parent as study evident that children age has impact on parents anxiety. Parent age was not taken due to guardian issue.
Total 100 parents were randomly divided into Intervention group (n=50) and Control Group (n=50). After excluding lost to follow up, the data was analyzed from 77 sample of parents (41 in intervention group and 36 in control group). The intervention group received multimedia education, booklet and weekly tele-nursing follow-up about chemotherapy and side effects management. The control group received routine care.
Participant milestones
| Measure |
Intervention
The Intervention group received multimedia education, booklet and weekly tele-nursing follow-up about chemotherapy and side effects management
|
Control
The Control group receive routine care
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
41
|
36
|
|
Overall Study
NOT COMPLETED
|
9
|
14
|
Reasons for withdrawal
| Measure |
Intervention
The Intervention group received multimedia education, booklet and weekly tele-nursing follow-up about chemotherapy and side effects management
|
Control
The Control group receive routine care
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
14
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intervention
n=41 Participants
The Intervention group will received multimedia education, booklet and weekly tele-nursing follow-up about chemotherapy and side effects management
Multimedia education, booklet Providence and tele-nursing follow-up: Multimedia education, booklet and weekly tele-nursing follow-up is about chemotherapy and side effects management
|
Control
n=36 Participants
The Control group will receive routine care
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
1. Child Age: · 2-4years
|
13 Participants
n=41 Participants
|
11 Participants
n=36 Participants
|
24 Participants
n=77 Participants
|
|
Age, Customized
1. Child Age: · 5-7years
|
10 Participants
n=41 Participants
|
8 Participants
n=36 Participants
|
18 Participants
n=77 Participants
|
|
Age, Customized
1. Child Age: · 8-12 years
|
12 Participants
n=41 Participants
|
12 Participants
n=36 Participants
|
24 Participants
n=77 Participants
|
|
Age, Customized
1. Child Age: · 13-18 years
|
6 Participants
n=41 Participants
|
5 Participants
n=36 Participants
|
11 Participants
n=77 Participants
|
|
Sex/Gender, Customized
2. Child Gender: · Male
|
24 Participants
n=41 Participants
|
26 Participants
n=36 Participants
|
50 Participants
n=77 Participants
|
|
Sex/Gender, Customized
2. Child Gender: · Female
|
17 Participants
n=41 Participants
|
10 Participants
n=36 Participants
|
27 Participants
n=77 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
3. Primary Care Giver:
Mother/Father
|
38 Participants
n=41 Participants
|
30 Participants
n=36 Participants
|
68 Participants
n=77 Participants
|
|
3. Primary Care Giver:
Others
|
3 Participants
n=41 Participants
|
6 Participants
n=36 Participants
|
9 Participants
n=77 Participants
|
|
4. Residency/Locality:
Local
|
17 Participants
n=41 Participants
|
11 Participants
n=36 Participants
|
28 Participants
n=77 Participants
|
|
4. Residency/Locality:
Non- Local
|
24 Participants
n=41 Participants
|
25 Participants
n=36 Participants
|
49 Participants
n=77 Participants
|
|
5. Occupation
Labor
|
24 Participants
n=41 Participants
|
18 Participants
n=36 Participants
|
42 Participants
n=77 Participants
|
|
5. Occupation
Shopkeeper
|
8 Participants
n=41 Participants
|
9 Participants
n=36 Participants
|
17 Participants
n=77 Participants
|
|
5. Occupation
Other
|
9 Participants
n=41 Participants
|
9 Participants
n=36 Participants
|
18 Participants
n=77 Participants
|
|
6. Level of education
Uneducated
|
11 Participants
n=41 Participants
|
11 Participants
n=36 Participants
|
22 Participants
n=77 Participants
|
|
6. Level of education
School Education
|
17 Participants
n=41 Participants
|
16 Participants
n=36 Participants
|
33 Participants
n=77 Participants
|
|
6. Level of education
Higher Education
|
13 Participants
n=41 Participants
|
9 Participants
n=36 Participants
|
22 Participants
n=77 Participants
|
|
7. Employment status
Daily Wages
|
28 Participants
n=41 Participants
|
21 Participants
n=36 Participants
|
49 Participants
n=77 Participants
|
|
7. Employment status
Monthly Salary
|
13 Participants
n=41 Participants
|
15 Participants
n=36 Participants
|
28 Participants
n=77 Participants
|
|
8. Income per month (Rupees)
less than 10,000
|
12 Participants
n=41 Participants
|
17 Participants
n=36 Participants
|
29 Participants
n=77 Participants
|
|
8. Income per month (Rupees)
More than 10,000
|
29 Participants
n=41 Participants
|
19 Participants
n=36 Participants
|
48 Participants
n=77 Participants
|
|
9 Child Diagnoses
Leukemia
|
28 Participants
n=41 Participants
|
23 Participants
n=36 Participants
|
51 Participants
n=77 Participants
|
|
9 Child Diagnoses
Other
|
13 Participants
n=41 Participants
|
13 Participants
n=36 Participants
|
26 Participants
n=77 Participants
|
|
10. Family History of cancer
No
|
34 Participants
n=41 Participants
|
33 Participants
n=36 Participants
|
67 Participants
n=77 Participants
|
|
10. Family History of cancer
Yes
|
7 Participants
n=41 Participants
|
3 Participants
n=36 Participants
|
10 Participants
n=77 Participants
|
|
11. Pain felt by the child
No
|
23 Participants
n=41 Participants
|
26 Participants
n=36 Participants
|
49 Participants
n=77 Participants
|
|
11. Pain felt by the child
yes
|
18 Participants
n=41 Participants
|
10 Participants
n=36 Participants
|
28 Participants
n=77 Participants
|
|
12. Do parent have smoking habits?
No
|
21 Participants
n=41 Participants
|
23 Participants
n=36 Participants
|
44 Participants
n=77 Participants
|
|
12. Do parent have smoking habits?
Yes
|
20 Participants
n=41 Participants
|
13 Participants
n=36 Participants
|
33 Participants
n=77 Participants
|
|
Depression
|
15.41 units on a scale
STANDARD_DEVIATION 5.97 • n=41 Participants
|
16.28 units on a scale
STANDARD_DEVIATION 7.32 • n=36 Participants
|
15.82 units on a scale
STANDARD_DEVIATION 6.6 • n=77 Participants
|
|
Anxiety
|
11.9 units on a scale
STANDARD_DEVIATION 6.51 • n=41 Participants
|
10.72 units on a scale
STANDARD_DEVIATION 7 • n=36 Participants
|
11.35 units on a scale
STANDARD_DEVIATION 6.72 • n=77 Participants
|
|
Stress
|
16.63 units on a scale
STANDARD_DEVIATION 5.96 • n=41 Participants
|
16.67 units on a scale
STANDARD_DEVIATION 6.45 • n=36 Participants
|
16.65 units on a scale
STANDARD_DEVIATION 6.15 • n=77 Participants
|
PRIMARY outcome
Timeframe: up to 4 weeksPopulation: Total 100 parents were enrolled and randomly allocated to (i)intervention group and (ii)Control group with equal number of allocations in each group respectively. The data were analyzed after excluding lost to follow up variables.
DASS-21 is comprised of questionnaires for three separate scales measuring Depression, Anxiety and Stress. The depression scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 28+, with higher scores indicating greater severity. The anxiety scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 20+, with higher scores indicating greater severity. The stress scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 37+, with higher scores indicating greater severity
Outcome measures
| Measure |
Intervention
n=41 Participants
The Intervention group received multimedia education, booklet and weekly tele-nursing follow-up about chemotherapy and side effects management
|
Control
n=36 Participants
The Control group will receive routine follow up.
|
|---|---|---|
|
Depression, Anxiety and Stress Scale - 21 (DASS-21)
Post-Depression (After 1 week)
|
6.44 score on a scale
Standard Deviation 3.94
|
9.72 score on a scale
Standard Deviation 5.82
|
|
Depression, Anxiety and Stress Scale - 21 (DASS-21)
Two- Week Post Depression (After 2 week)
|
2.63 score on a scale
Standard Deviation 2.98
|
6.11 score on a scale
Standard Deviation 4.94
|
|
Depression, Anxiety and Stress Scale - 21 (DASS-21)
Post-Anxiety (After 1 week)
|
4.2 score on a scale
Standard Deviation 3.43
|
6.61 score on a scale
Standard Deviation 5.23
|
|
Depression, Anxiety and Stress Scale - 21 (DASS-21)
Two- Week Post Anxiety (After 2 week)
|
1.75 score on a scale
Standard Deviation 2.33
|
4.27 score on a scale
Standard Deviation 3.61
|
|
Depression, Anxiety and Stress Scale - 21 (DASS-21)
Post-Stress (After 1 week)
|
7.02 score on a scale
Standard Deviation 4.59
|
11 score on a scale
Standard Deviation 6.3
|
|
Depression, Anxiety and Stress Scale - 21 (DASS-21)
Two- Week Post Stress (After 2 week)
|
2.88 score on a scale
Standard Deviation 3.1
|
6.83 score on a scale
Standard Deviation 5.22
|
Adverse Events
Intervention
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Nomi Waqas Gul, Student MSN DUHS ION and Asst. Controller Sindh Nurses Examination Board, Karachi
Institute of Nursing Dow University of Health Sciences, Karachi/Sindh Nurses Examination Board, Karachi
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place