UMIN-CTR Clinical Trial

Public title

The effects of cold compresses on itching in patients with atopic dermatitis: A cross-over controlled trial

Acronym

The effects of cold compresses on itching in patients with atopic dermatitis: A cross-over controlled trial

Scientific Title

The effects of cold compresses on itching in patients with atopic dermatitis: A cross-over controlled trial

Scientific Title:Acronym

The effects of cold compresses on itching in patients with atopic dermatitis: A cross-over controlled trial

Region

Japan

Condition

atopic dermatitis

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study was to investigate whether cold compresses are effective and safe for reducing itching in patients with atopic dermatitis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The visual analogue scale was used to measure itching with ranging from 0 (as a complete absence) to 100 (as the strongest sensation). Measurements were compared before and after the cold compress.

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

All participants were treated with two types of cold compress, with each intervention using the same protocol with the only difference between each intervention being the materials used for the cold compress.
The experiment consisted of 5 phases: In phase 1, participant baseline data were measured. The baseline temperatures were measured for five minutes.
In phase 2, a room-tempered compress was placed on the participants for five minutes. After a 5-minute interval (phase 3), a cold compress was set for five minutes (phase 4). The participants remained on the bed for the next 15 minutes while their vital signs were monitored, which constituted phase 5.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) having been diagnosed with AD by a physician
2) being aware of a chronic itching for more than 6 months

Key exclusion criteria

currently experiencing severe disease

Target sample size

17

Name of lead principal investigator

1st name	YUKI
Middle name
Last name	HIRAMI

Organization

Okayama University

Division name

Academic Field of Health Sciences

Zip code

700-8558

Address

2-5-1 Shikata-Cho, Kita-ku, Okayama

TEL

+81862356860

Email

yhirami@md.okayama-u.ac.jp

Name of contact person

1st name	YUKI
Middle name
Last name	HIRAMI

Organization

Okayama University

Division name

Academic Field of Health Sciences

Zip code

700-8558

Address

2-5-1 Shikata-Cho, Kita-ku, Okayama

TEL

+81-86-235-6860

Homepage URL

Email

yhirami@md.okayama-u.ac.jp

Institute

Okayama University

Institute

Department

Personal name

YUKI HIRAMI

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

The Department of Nursing Ethic Committee of Okayama University Graduate School of Health Science

Address

2-5-1 Shikata-Cho, Kita-ku, Okayama

Tel

+81-86-235-7984

Email

kangorinri@okayama-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

10

Month

31

Day

URL releasing protocol

-

Publication of results

Unpublished

URL related to results and publications

-

Number of participants that the trial has enrolled

19

Results

In intervention with towel, the mean and standard deviation of the itching in VAS was 16.9(19.1) (Time1), 11.6(15.7) (Time2), 11.4(16.1)(Time3), and 7.7(9.2)(Time4). In intervention with ice pack, VAS was 13.6(14.7) (Time1), 12.4(13.7) (Time2), 6.2(9.8) (Time3), and 7.2(8.5) (Time4). Friedman's test revealed significant differences in itching for the towel (p = 0.006, effect size = 0.23) and ice pack interventions (p=0.005, effect size=0.23) over the four-time points.

Results date posted

2023

Year

10

Month

23

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

19 participants (14 female: 73.7%).
Mean age 28.3 years (range: 19-75).
More than 95% of participants had mild or moderate.
Fourteen of the 19 participants continued treatment.
Sixteen of the 19 participantas were using steroid ointments.

Participant flow

This study employed convenience sampling by recruiting through poster displays in hospitals, universities, and referrals from university faculty. A total of 19 participants, 10 through recruitment and 9 through referrals, met the inclusion criteria. No one dropped out.

Adverse events

No adverse events to report.

Outcome measures

In intervention with towel, the mean and standard deviation of the itching in VAS was 16.9(19.1) (Time 1), 11.6(15.7) (Time 2), 11.4(16.1) (Time 3), and 7.7(9.2) (Time 4). In intervention with ice pack, the mean and standard deviation of the itching in VAS was 13.6(14.7) (Time 1), 12.4(13.7) (Time 2), 6.2(9.8) (Time 3), and 7.2(8.5) (Time 4). Friedman's test revealed significant differences in itching for the towel (p = 0.006, effect size = 0.23) and ice pack interventions (p = 0.005, effect size = 0.23) over the four-time points. However, further analysis using the Wilcoxon signed-rank test with Bonferroni correction did not show a significant difference in efficacy between the four-time points in the two interventions, respectively.
We then compared the effect of the cold compress between Time1 and Time 3 (towel: p= 0.003; ice pack: p= 0.001). The relation between the presence of itching at baseline and the effect of cold compress was analyzed using Fisher's exact test.
The VAS values for coldness (p<0.001, p<0.001) and pain (p=0.023, p=0.038) were significantly higher during cooling. However, there was no statistically significant difference for discomfort (p=0.14, p=0.23, interventions towel and ice pack, respectively).
In both interventions, the heart rate was significantly lower after the experiment was conducted (p = 0.004, p = 0.003, in interventions towel and ice pack respectively). Skin temperature, in-bed climate, and temperature of the materials used were measured to note any differences in the respective temperatures in the two interventions. During phase 2, the temperature of the materials and the cubital fossa were significantly lower in intervention with towel than in intervention with ice pack (p= 0.015, p< 0.001, p = 0.001). There were no significant differences in the measured temperatures other than the above.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2018

Year

07

Month

01

Day

Date of IRB

2018

Year

05

Month

28

Day

Anticipated trial start date

2018

Year

07

Month

10

Day

Last follow-up date

2018

Year

10

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

10

Month

30

Day

Last modified on

2024

Year

10

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059988