The methodology used in carrying out the study is described under four designs, namely, technical, operational, administrative, and statistical designs. The technical design includes the research design, study setting, sample, and tools of data collection.
Research design
Mixed-methods study
This study was designed as a mixed-method study. It involved a sequential mixed-method approach, in which both quantitative data collection and analysis techniques were chronologically undertaken [21, 22]. The study began with a quantitative study and was followed by a qualitative one. Finally, a mixed-method analysis was undertaken for this study, in order to answering the research question.
Study setting
The present study was carried out at the Faculty of Nursing, Ain Shams University.
Participants
A convenient sample of 50 academic students was recruited.
Inclusion criteria
The study included students having TTH recurrence and willing to participate in the study.
Tools of data collection
Three tools were used to collect data for this study.
Tool I: A structured interview sheet was used for the sociodemographic data. It included six items that elicit sociodemographic characteristics of students under study, such as age, level of education, marital status, residence, and income.
Tool II: This was a stress-based scale used to assess the effect of stress on physical and psychological well-being, which was adopted from Abdullah et al. [23].
Tool III: This was a TTH questionnaire adapted from Mahmoud et al. [4].
Operational design
The operational design for this study includes preparatory phase, pilot study, fieldwork, ethical considerations, and limitations of the study.
Preparation phase
This phase deals with the preparation of the study design; data collection tool was adapted by the researcher. TTH questionnaire was primarily developed in English, which needed to be translated into Arabic. Reviewing literature studies and other available resources related to TTH, stress, among academic students, and role of cryotherapy to relieve tension-type headache, for the preparations of data collection tools.
Content validity and reliability of the tools
Tool II was tested for its content validity and reliability by Abdullah et al. [23]. The tools were tested for their content validity by a jury of thirteen experts in the field of psychology, such as counseling psychology, education, curriculum, and teaching, who ascertained their validity and relevance. The α Chronbach test was used to measure the internal consistency (reliability of the used tool). Tool III: tension-type headache-based questionnaire was tested for its content validity and reliability by Mahmoud et al. [4].
Pilot study
A pilot study was carried out before starting the data collection phase. It included ten students. It was conducted to evaluate the simplicity, practicability, legibility, understandability, feasibility, validity, and reliability of the tools, and to assess stress and TTH. No modifications were done for tools s of data collection.
Fieldwork
Fieldwork of the current study was divided into two stages:
Stage I: It started by reading and exploring related information in scientific magazines and preparing tools of data collection. Then, it dealt with formulating clear and evidence-based scientific data and ideas about cryotherapy and consulting professor of neuropsychiatry about the research idea. This stage takes about 2 years. Then, the dean of the faculty and subjects of the study were informed about the purpose of the study. After that, oral consent was taken, from subjects of the study, after informing them about their right to participate in the study and the information used will be for the sole purpose of the study. The study was conducted on an individual and group basis. Each student can be interviewed individually or with group according to students’ circumstances. Each interview lasted for 15–30 min, 3 days per week. The researcher asked the subjects regarding the needed information and then data filled in the two questionnaires (TTH and stress). After that, instructional guidelines about cryotherapy had been given by focused group discussion. The process of data collection took a period of 1 month from November 2015 to December 2015.
Stage II: Instructional guidelines about cryotherapy (ice compression) were introduced for a group of six students as follows:
The subjects of the study were informed about the therapeutic use of locally applied coolants at the back of the neck and its effect in reducing TTH. Conduction occurs when a cool ice compress that applied to the skin at the back of the neck. Cryotherapy has historically been used to provide pain relief. Cryotherapy may additionally be used to elevate the pain threshold. As cooling decreases tissue temperatures, the sensory nerves in the skin are provoked to fire continuously until physiologically exhausted. Usually this causes the participant to predictably experience a sequence of sensations including aching, burning, and finally numbness. Numbness or temporary local anesthesia occurs as the sensory nerves are exhausted. Deeper nerves (below the epidermis) may also be affected by cooling. Muscle cooling has been shown to affect the afferent nerves. This occurs in the muscle after 10 min of cooling with an ice pack. All nerve fibers are generally affected by cooling. Additionally, cooling has been shown to affect the various vascular structures at all levels to the extent of causing an initial reflex vasoconstriction to occur. Vasoconstriction has been shown to reduce blood flow in tissues cooled to 18 °C. As cooling continues, vasodilatation occurs in a physiological attempt to increase blood flow and thereby prevent tissue damage. This phenomenon is called the hunting reaction.
Cryotherapy is most commonly applied as ice packs, which may be created by putting ice in a plastic bag or by freezing a moistened hydrocollator. A damp towel should be frozen. The towel is then placed over the treatment site for 10–20 min or until sensory analgesia (temporary local anesthesia) of the skin is produced. This stage took about 1 month, with six sessions, from December 2015 to January 2016. After discussing these instructional guidelines about cryotherapy (ice compresses), the students were followed up and asked frequently about the effect of ice compression on relieving TTH. The students’ responses were satisfactory, to a large extent. They stated that TTH and mental tension had been relieved to a very little degree.
Research has shown that during ice compression application, a decline in fast-twitch muscle fiber tension occurs, resulting in a more significant recruitment of slow-twitch muscle fibers, thereby increasing muscle endurance. Because vasoconstriction leads to a decrease in metabolic rate, inflammation, and pain, cryotherapy is usually applied for 20–30min for maximum cooling of both superficial and deep tissues. The cold agent should be applied directly to the skin for optimal therapeutic effects.
Ethical consideration
The researcher obtained an approval to conduct the research study and received official permission from the authority of Faculty of Nursing, Ain Shams University. After obtaining official requirements for carrying out this study, the subjects of the study were informed about the aim and nature of the study, their right to participate in the study, and their right to withdraw at any time without giving any reason and provided reassurance about confidentiality of their information and that data collected will be used only for the purpose of the research.
Limitation of the study
On proceeding the subjects of the study regarding applying ice compresses at the back of the neck in the early morning, some faced difficulties such as follows: the study was conducted in winter, it was too cold to apply the ice compresses; some stated that they reside in a university hotel and there is no availability of ice compress as in their home; others stated that they work in nightshift, which means they are not at home; and others stated that they forgot to place ice compresses when getting up early in the morning. Only six students followed the instructional guidelines about cryotherapy and continued applying ice compresses.
Administrative design
An official letter was addressed to the dean of faculty of nursing, requesting her cooperation and permission to conduct the study. After explanation of the study objectives, the researcher obtained the written permission. Complete confidentiality of any obtained information was ensured.
Statistical design
Data analysis
Data entry and statistical analysis were done using SPSS statistical software package. IBM Corp. Released 2012. IBM SPSS Statistics for Windows, Version 21.0. Armonk, NY: IBM Corp. quantitative continuous data were compared. Qualitative categorical variables were compared using χ2 test. Statistical significance was considered at P value of less than0.05.
The focus group is the qualitative part.
Design and ethics consideration
The study involved a descriptive qualitative study. It aimed to seek how cryotherapy can relieve TTH. Data were collected using semi-structured interviews with six academic students in the faculty of nursing and four academic staff at work.
An interview guideline was developed with three main questions subdivided to many questions as follows:
-
(1)
What are symptoms associated with TTH?
- (a)
Times of recurrence?
- (b)
Characteristics of tension feeling?
- (c)
Feeling of depressive symptoms?
- (d)
Anxiety symptoms?
- (e)
Level of performance of daily activities?
- (f)
Mood changes?
- (g)
Sleep quality?
- (h)
Appetite?
-
(2)
What is the effect of ice compresses on TTH?
- (a)
Do ice compressions relieve TTH?
- (b)
The recurrence of headache
- (c)
The intensity of headache
- (d)
Mental tension after ice compresses
- (e)
Stress feeling
-
(3)
Did you observe any physical problems after using ice compresses?
Participants
The participants were six students, who had TTH and mental tension. They were recruited by a purposive sampling. This sampling method was selected because the study aimed to obtain information from the students with a greater breadth and depth of knowledge regarding tension headache and mental tension.
Data collection
Data were collected using semi-structured interviews among the recruited students. Before starting of each interview, students were informed about the study, such as the aim of study. In addition, permission to write the interview was sought from each participant. All interviews were conducted in the same pattern according to an interview guideline. Each interview lasted ~ 30 min. To ensure the consistency of interview, no more than five interviews per day were conducted.
Data analysis
There were two main processes for data analysis: (a) data preparation and (b) data analysis. The process of data preparation involved transcription and translation. Interview data were transcribed from spoken words into textual data by the researcher. After that, transcriptions were translated into English by the researcher.
Textual data from the interviews were manually analyzed by using thematic analysis technique, which is a method for identifying, analyzing, and reporting themes and concepts with qualitative data [24].
Data were analyzed using the six steps of thematic analysis suggested by Braun et al. [24],
which included the following: (a) familiarizing with the data, (b) generating initial codes, (c) searching for themes, (d) reviewing themes, (e) defining themes, and (f) producing the report.
Qualitative findings were used to examine the effect of cryotherapy on relief of TTH.
Mixed-methods analysis
As mixed-methods designs, findings from both the qualitative and quantitative studies were integrated at the final stage. The findings of both studies were combined in two ways. First, as the findings of the cross-sectional study were reported in a numeric form, these may be too abstract to explain the detail of cryotherapy on relief of TTH among academic students.
Consequently, the interpretation of the findings using two different research approaches offered a breadth and depth of understanding about the status of TTH after proceeding cryotherapy (ice compresses).