Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05486624 |
| Other study ID # |
AhiEvranU |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2020 |
| Est. completion date |
June 30, 2021 |
Study information
| Verified date |
August 2022 |
| Source |
Kirsehir Ahi Evran Universitesi |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Purpose: To investigate the effect of Reiki application on postpartum episiotomy recovery and
perineal pain in postpartum women who had vaginal delivery.
Design and framework: The research is randomized controlled in a pre-test post-test order in
a hospital in Turkey. By using Simple Random Numbers Table as the randomization method in the
selection of the sample, a total of 86 puerperal women, 40 in the intervention group and 46
in the control group, were recruited. Episiotomy recovery of the intervention and control
groups on the 1st day, 2nd day, 7th day, and 14th day postpartum was evaluated with the REEDA
Scale, and perineal pain was evaluated with the McGill Pain Scale Short Form.
Participants: Postpartum women who gave vaginal birth participated in the study.
Intervention: 3 sessions of Reiki for 35-40 minutes were applied to the intervention group on
the 1st, 2nd and 7th days of birth.
Results: There was a significant difference between the mean REEDA Scale edema scores in the
7th day (p=0.028) and 14th day (p=0.013) follow-up of the intervention and control groups. A
significant difference was found between the 3rd post-test McGill Pain Scale Short Form total
pain score averages (p=0.005) and the 4th follow-up McGill Pain Scale Short Form total pain
score averages (p=0.001) of the intervention and control groups.
Description:
The research is randomized controlled in the pre-test post-test order. This research has been
reported in accordance with the CONSORT (Consolidated Standards of Reporting Trials)
guidelines. Before working at the hospital, ethics committee approval (Number:
99166796-050.06.04) from Ege University Faculty of Medicine Dean's Medical Research Ethics
Committee and institutional permission from Kırşehir Governorship Provincial Health
Directorate Kırşehir Public Hospitals Services Unit (No: 42884709-806.99). The aim and
content of the research were explained to the puerperants orally. In addition, verbal and
written consent was obtained from the puerperants using the Informed Voluntary Consent Form.
Postpartum women were informed that they have the right to leave the study whenever they
want.
Randomization Simple Random Numbers Table was used as the randomization method in the sample
selection of the study. Among the puerperant women who met the initial inclusion criteria,
those who accepted to participate in the study were included in the application of
randomization. Then, a randomly sorted algorithm was created at the maximum allowed
percentage, with a deviation of 10%, in a total of 100 samples. In the algorithm, 50 sample
(postpartum) groups for both groups; Up to 100 randomly sorted as A and B. Intervention
group: A, Control group: B. The sample taken according to the order in the list on the data
collection days; It is accepted as group A or B. In terms of equality according to the number
of births of the groups, 50 sample groups were randomly divided into 2 groups of 25 each
without being randomized. Two groups were formed as 25 puerperant primiparous group and 25
puerperal multiparous group. In the study, since the numbers in the multiparous group were
completed earlier than in the primiparous group, the sampling was continued until the number
of the primiparous group was completed.
Participants and Framework The smallest sample size to be taken in the research; In order to
find the significant difference between the groups, repeated measurement variance analysis
was determined by using Power (Gpower) analysis under the test. In the analysis, α=0.05 and
f=0.25 (medium effect size) were taken with 80% power, and 78 cases were found to be
sufficient. Considering the loss of follow-up, the number of samples was increased to 100. A
total of 100 puerperant women, 50 puerperant women for each group, were included in the
study. When the sample size was 100 cases, the power of analysis was checked again. The
strength of the work "G. Calculated using the "Power-3.1.9.2" program. As a result of the
analysis applied to 86 people, 40 in the intervention group and 46 in the control group, α =
0.05, the effect size was found to be 0.7882, and the power of the study, which was
calculated as post-hoc, was calculated as 0.95. Patients aged 18 and over, no risky pregnancy
(no systemic disease, no smoking, no postpartum complications), 37-42 weeks of gestation,
single and live vaginal delivery, performed mediolateral episiotomy, no vaginal infection,
any drug Postpartum women who do not use, do not have any laceration (anal sphincter injury,
3rd degree perineal laceration) other than episiotomy, use only clean water for perineal care
and keep them dry are included. The puerperant women who had lacerations other than
episiotomy, who did not meet the standards of using clean water in perineum care and keeping
them dry (doing different care or using pharmacological products), and who did not accept
home visits were excluded from the study. Out of 100 puerperant women included in the sample,
although they initially accepted the home visit, 8 of them could not be reached for home
visits, 3 of them were out of the province on the day of the home visit, 2 of them did not
accept home visits, and 1 of them did not comply with the standard in perineal care. In the
4th follow-up, no home visit was made. In the intervention group; 10 puerperant women, 7 from
the primiparous group and 3 from the multiparous group, did not complete the study. In the
control group; 4 puerperant women, 2 from the primiparous group and 2 from the multiparous
group, did not complete the study. Before the research, a pilot study was conducted with 12
puerperal women. The puerperant women taken in the pilot study were not included in the
sample.
Introductory Information Form was used in the intervention and control groups on the 1st day
of delivery by face-to-face interviews with the postpartum in the hospital. REEDA Scale,
MAI-SF were used on the 1st, 2nd, 7th and 14th days of delivery in both groups. Both groups
were given the Episiotomy Care Training Brochure on the 1st day of birth and the Follow-up
Form, which they would fill in within 14 days and be taken from them at the last follow-up.
Intervention and control group; It was evaluated by making a home visit on the 1st day and
the 2nd day in the hospital, and on the 7th and 14th days. The records of the forms were
filled by the researcher. Data collection time took approximately 15 minutes for the control
group and approximately 50-55 minutes for the intervention group.
