UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050558 |
|---|---|
| Receipt number | R000057547 |
| Scientific Title | Development and Effectiveness of a Fatigue Reduction Program for Women with Children - Using an integrative approach with cognitive behavioral therapy and complementary and alternative therapies |
| Date of disclosure of the study information | 2023/03/10 |
| Last modified on | 2023/03/10 16:26:47 |
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Basic information
Public title
Development and Effectiveness of a Fatigue Reduction Program for Women with Children - Using an integrative approach with cognitive behavioral therapy and complementary and alternative therapies
Acronym
Development and Effectiveness of a Fatigue Reduction Program for Women with Children
Scientific Title
Development and Effectiveness of a Fatigue Reduction Program for Women with Children - Using an integrative approach with cognitive behavioral therapy and complementary and alternative therapies
Scientific Title:Acronym
Development and Effectiveness of a Fatigue Reduction Program for Women with Children
Region
| Japan |
Condition
Condition
fatigue of women with children
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effectiveness of fatigue reduction programs for women with children.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate the effectiveness of fatigue reduction programs with the Postpartum Accumulated Fatigue Scale (PAFS).
Key secondary outcomes
The secondary effects of the Fatigue Reduction Program will be evaluated using the Visual Analog Scale (VAS), the Simple Menopausal Index (SMI), the Parenting Self-Efficacy Scale (PSE), the Athens Insomnia Scale (AIS), Cognitions in Child Care, and the results of interviews (perceptions and changes after attending the program).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Attend 1st online training (40 min), conduct homework (continued until 2nd training) - Attend 2nd online training (30 min), conduct homework (continued until email consultation) - Email consultation (1 time, 1 week after 2nd training), continue homework (5 weeks)
Interventions/Control_2
Life as usual(10 weeks) - Those who wish to do so will receive the same program as Intervention 1.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 35 | years-old | <= |
Age-upper limit
| 55 | years-old | > |
Gender
Female
Key inclusion criteria
Women over 35 years old who are raising a child between 1 and 4 years old.
Mother and child are healthy.
Women who live with their husbands or partners.
Japanese nationals residing in Japan.
Have sufficient Japanese language ability to answer the questionnaire.
Those who often feel tired from childcare in the last month.
Those who have an Internet environment necessary for attending the program.
Key exclusion criteria
Those who do not meet the selection criteria.
Those who cannot give consent to participate in this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takako |
| Middle name | |
| Last name | Uetake |
Organization
Juntendo University
Division name
Faculty of Health Care and Nursing
Zip code
279-0023
Address
2-5-1 Takasu, Urayasu, Chiba 279-0023, Japan
TEL
047-350-3111
tuetake@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Takako |
| Middle name | |
| Last name | Uetake |
Organization
Juntendo University
Division name
Faculty of Health Care and Nursing
Zip code
279-0023
Address
2-5-1 Takasu, Urayasu, Chiba 279-0023, Japan
TEL
047-350-3111
Homepage URL
tuetake@juntendo.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Takako Uetake
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Faculty of Health Care and Nursing
Address
2-5-1 Takasu, Urayasu, Chiba 279-0023, Japan
Tel
047-350-3111
tuetake@juntendo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 10 | Day |
Related information
URL releasing protocol
https://ganbaranaiikuji.com/
Publication of results
Unpublished
Result
URL related to results and publications
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-20K10947/
Number of participants that the trial has enrolled
200
Results
Comparison between the two groups showed intervention effects on "PAFS, irritability," "SMI, irritability," and the parenting cognitions sub-item, and comparison between pre- and post-intervention showed intervention effects on "SMI," "PSE," "sleep," and "parenting cognitions" (p <.05). These results suggest that the program was effective in improving subjective symptoms of irritability and parenting cognitions.
Results date posted
| 2023 | Year | 03 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
1. Background of all subjects
The mother's age was 38.4 (SD 2.96), the number of children was 1.79 (SD 0.76), the age of the first child was 3.86 (SD 1.38), the age of the second child was 2.88 (SD 1.43) and the age of the third child was 2.63 (SD 1.31). The sleep duration 6.47 (SD 0.94).
Satisfaction with child care support was means support 2.6 (SD 0.8), information support 2.77 (SD 0.73), evaluation support 2.64 (SD 0.91), and emotional support 2.47 (SD 0.99). Employment status was 70 (50.0%) employed and 70 (50.0%) not employed. Household financial concerns were 77 (55.0%) yes and 63 (45.0%) no. Marital status was married 139 (99.3%) and never married 1 (0.7%). Family type was nuclear family 125 (89.3%) and extended family 15 (10.7%). Caregiving status was 135 (96.4%) without caregiving and 5 (3.6%) with caregiving.
2. Participant background by group
Intervention group
Age of mother 38.5 (SD 3.05), number of children 1.72 (SD 0.75), age of first child 3.75 (SD 1.42), age of second child 2.90 (SD 1.39), age of third child 2.5 (SD 1.51). Sleep duration 6.48 (SD 0.96).
Satisfaction with child care support was means support 2.65(SD0.8), information support 2.77 (SD0.71), evaluation support 2.69 (SD 0.84), and emotional support 2.43 (SD0.92). Employment status was 43 (57.3%) with employment and 32 (42.7%) without employment. Forty-one (54.7%) were concerned about their household finances and 34 (45.3%) were not concerned about their household finances. Marital status was 74 (98.7%) married and 1 (1.3%) never married. Family type was nuclear family: 69 (92.0%) and extended family: 6 (8.0%).
Caregiving status was 43 (97.3%) without caregiving and 2 (2.7%) with caregiving.
Control group.
Age of mother 38.3 (SD 2.86), number of children 1.86 (SD 0.77), age of first child 3.98 (SD 1.32), age of second child 2.86 (SD 1.49), age of third child 2.69 (SD 1.18) sleep duration 6.46 (SD 0.92).
Satisfaction with child care support included satisfaction with instrumental support 2.54 (SD 0.81), satisfaction with informational support 2.77(SD 0.77), satisfaction with evaluative support 2.58 (SD1.00), and satisfaction with emotional support 2.52 (SD1.08). Employment status was 27 (41.5%) with employment and 38 (58.5%) without employment. Household financial status was 36 (55.4%) were concerned about their household finances and 29 (44.6%) were not concerned about their household finances. Marital status was 65 (100%) married. Family status was nuclear family 56 (86.2%) and extended family 9 (13.8%).
Caregiving status was 62 (95.4%) without caregiving and 3 (4.6%) with caregiving.
In all of the above, there were no statistically significant differences between the two groups, the intervention group and the target group (p >.05).
Participant flow
A screening survey was conducted among 16,864 registered members of a Web-based social research company, from which 5,759 were selected.
Of the 5,759, 927 who consented to participate in the study were assigned to two groups, 100 in the intervention group and 100 in the control group, using a stratified random assignment method according to child age (1, 2, 3, and 4 years old).
The pre-intervention survey (Time 1) was distributed to 100 intervention and 100 control subjects, and was collected from 93 (93%) intervention subjects and 82 (82%) control subjects.
The first video viewing survey was distributed to the subjects who responded to the pre-intervention survey, and 92 (92%) viewed the video.
A second video viewing questionnaire was sent to the subjects who viewed the first video, and 89 (89%) viewed the second video.
An individual consultation questionnaire was distributed to the subjects who watched the second video, and 81 (81%) responded.
In the 2-week post-intervention survey (Time 2), responses were obtained from 78 (78%) in the intervention group and 75 (75%) in the control group. Finally, at the 4-week post-intervention survey (Time 3), responses were obtained from 75 (75%) in the intervention group and 65 (65%) in the control group.
Adverse events
No adverse events
Outcome measures
1. Comparison between the two groups
PAFS (Irritability): the two-way analysis of variance showed a main effect with and without intervention (F (1, 138) = 4.635, p <.05). Therefore, a t-test with and without intervention showed that the intervention group tended to have significantly lower "irritability scores" than the control group at Time 3 (t = -1.978, p = .05, d = .34)
SMI (Irritability): The two-way analysis of variance showed a main effect by intervention (F (2, 256) = 3.164, p <.05). Therefore, a t-test by intervention presence/absence revealed statistically significant differences at time 2 (t = -2.684, p <.05, d = 0.45) and time 3 (t = -2.650, p <.05, d = 0.45).
Cognition during child-rearing, sub-item: a two-way ANOVA revealed an interaction for "Wives want their husbands to understand their feelings without words" (F (2, 276) = 5.652, p <.05). A main effect was also found for "I think I am a bad mother if my room is messy" by time (F (2, 276) = 9.864, p <.05).
Therefore, t-tests were conducted with and without intervention, and statistically significant differences were found in Time 2 (t = -2.204, p <.05, d = 0.37) for "Husbands should understand their wives' feelings without words" and in Time 3 (t =-2.057, p <.05, d = 0.35) for "I feel like a bad mother if my room is messy". statistically significant difference was found at Time 3 (t = -2.057, p <.05, d = 0.35).
2. Pre- and post-intervention comparisons
PSE: The intervention group showed significant increases in scores at Time 1 45.3 (SD 7.1) and Time 2 47.1 (SD 7.0) and at Time 1 (SD 7.1) and Time 3 47.7 (SD 7.2) (p <.01). The control group showed no statistically significant differences at any combination of time periods.
Sleep (AIS): The intervention group showed a significant decrease in scores at Time 1 6.7 (SD 3.0) and Time 3 5.5 (SD 3.2) (p <.01). The control group showed no statistically significant differences in any of the time period combinations.
Cognition of Parenting Period (7 items): The intervention group showed a significant decrease in scores at Time 1 20.3 (SD 4.4) and Time 2 18.3 (SD 5.3) (p <.01, d = .42), and at Time 1 20.3 (SD 4.4) and Time 3 17.5 (SD 5.8) (p <.01, d = .54). The control group showed no statistically significant differences at any combination of time periods.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 22 | Day |
Date of closure to data entry
| 2021 | Year | 10 | Month | 06 | Day |
Date trial data considered complete
| 2021 | Year | 10 | Month | 26 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 10 | Day |
Last modified on
| 2023 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057547
